Trial Outcomes & Findings for Dysphagia Following Anterior Cervical Spine Surgery; Single Dose Steroid vs Saline (DysDexVSSal) (NCT NCT03711474)
NCT ID: NCT03711474
Last Updated: 2025-02-12
Results Overview
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
COMPLETED
PHASE4
78 participants
Baseline to Day 1
2025-02-12
Participant Flow
Participant milestones
| Measure |
Treatment 1; Dexamethasone
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
38
|
|
Overall Study
COMPLETED
|
38
|
38
|
|
Overall Study
NOT COMPLETED
|
2
|
0
|
Reasons for withdrawal
| Measure |
Treatment 1; Dexamethasone
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Overall Study
Physician Decision
|
2
|
0
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Treatment 1; Dexamethasone
n=40 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=38 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Total
n=78 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=40 Participants
|
0 Participants
n=38 Participants
|
0 Participants
n=78 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
28 Participants
n=40 Participants
|
31 Participants
n=38 Participants
|
59 Participants
n=78 Participants
|
|
Age, Categorical
>=65 years
|
12 Participants
n=40 Participants
|
7 Participants
n=38 Participants
|
19 Participants
n=78 Participants
|
|
Age, Continuous
|
56.53 years
STANDARD_DEVIATION 10.99 • n=40 Participants
|
55.53 years
STANDARD_DEVIATION 9.09 • n=38 Participants
|
56.04 years
STANDARD_DEVIATION 10.06 • n=78 Participants
|
|
Sex: Female, Male
Female
|
23 Participants
n=40 Participants
|
22 Participants
n=38 Participants
|
45 Participants
n=78 Participants
|
|
Sex: Female, Male
Male
|
17 Participants
n=40 Participants
|
16 Participants
n=38 Participants
|
33 Participants
n=78 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: Baseline to Day 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia -Bazaz Scale
|
2.17 score on a scale
Standard Deviation 2.01
|
3.27 score on a scale
Standard Deviation 1.88
|
PRIMARY outcome
Timeframe: Baseline to Day 2Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia -Bazaz Scale
|
2.25 score on a scale
Standard Deviation 2.02
|
3.16 score on a scale
Standard Deviation 1.98
|
PRIMARY outcome
Timeframe: Baseline to Week 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=35 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia -Bazaz Scale
|
1.61 score on a scale
Standard Deviation 1.76
|
2.06 score on a scale
Standard Deviation 1.62
|
PRIMARY outcome
Timeframe: Baseline to Week 2Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=38 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia -Bazaz Scale
|
1.03 score on a scale
Standard Deviation 1.52
|
1.24 score on a scale
Standard Deviation 1.57
|
PRIMARY outcome
Timeframe: Baseline to Month 3Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=37 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=36 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia -Bazaz Scale
|
0.16 score on a scale
Standard Deviation 0.54
|
0.47 score on a scale
Standard Deviation 1.03
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=35 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=35 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia -Bazaz Scale
|
0.26 score on a scale
Standard Deviation 0.74
|
0.24 score on a scale
Standard Deviation 0.70
|
PRIMARY outcome
Timeframe: Baseline to Month 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=38 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia -Bazaz Scale
|
0.95 score on a scale
Standard Deviation 1.35
|
0.62 score on a scale
Standard Deviation 1.06
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis.
Change from baseline scores on the dysphagia Bazaz Scale. • Bazaz grading system is designed for the evaluation of swallowing difficulty after cervical surgery. The patients are graded on a scale as having None (0), Mild (1), Moderate (2), or Severe (3) dysphagia based on their symptoms. None (0) or Mild (1) dysphagia is considered to be a better outcome.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=35 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia -Bazaz Scale
|
0.28 score on a scale
Standard Deviation 0.88
|
0.06 score on a scale
Standard Deviation 0.24
|
PRIMARY outcome
Timeframe: Baseline to Day 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
|
2.81 score on a scale
Standard Deviation 2.73
|
3.76 score on a scale
Standard Deviation 2.28
|
PRIMARY outcome
Timeframe: Baseline to Day 2Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
|
3.22 score on a scale
Standard Deviation 2.63
|
3.5 score on a scale
Standard Deviation 2.56
|
PRIMARY outcome
Timeframe: Baseline to Week 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia DSQ. Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=35 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
|
2.92 score on a scale
Standard Deviation 3.41
|
3.75 score on a scale
Standard Deviation 3.08
|
PRIMARY outcome
Timeframe: Baseline to Week 2Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
|
1.89 score on a scale
Standard Deviation 2.98
|
2.62 score on a scale
Standard Deviation 2.73
|
PRIMARY outcome
Timeframe: Baseline to Month 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=38 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
|
1.79 score on a scale
Standard Deviation 2.48
|
1.73 score on a scale
Standard Deviation 2.26
|
PRIMARY outcome
Timeframe: Baseline to Month 3Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=37 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=36 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
|
0.62 score on a scale
Standard Deviation 1.38
|
0.86 score on a scale
Standard Deviation 1.17
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia DSQ.• Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=35 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
|
0.56 score on a scale
Standard Deviation 1.11
|
0.23 score on a scale
Standard Deviation 0.65
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia DSQ. • Dysphagia Short Questionnaire (DSQ) is designed for the evaluation of swallowing difficulty after cervical surgery. Each question is given a weighted number from 0 points up to 4 points. The total score is calculated by summing up the points given for each item with the total range being from 0 points to a maximum of 18 points. The lower scores represent milder symptoms, and higher scores represent worse symptoms.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=35 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=35 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Dysphagia Short Questionnaire (DSQ).
|
0.86 score on a scale
Standard Deviation 1.87
|
0.82 score on a scale
Standard Deviation 1.64
|
PRIMARY outcome
Timeframe: Baseline to Day 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
|
11.89 score on a scale
Standard Deviation 10.28
|
17.49 score on a scale
Standard Deviation 8.86
|
PRIMARY outcome
Timeframe: Baseline to Day 2Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
|
11.89 score on a scale
Standard Deviation 10.86
|
15.73 score on a scale
Standard Deviation 10.87
|
PRIMARY outcome
Timeframe: Baseline to Week 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=38 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=38 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
|
8.22 score on a scale
Standard Deviation 9.88
|
9.89 score on a scale
Standard Deviation 9.88
|
PRIMARY outcome
Timeframe: Baseline to Week 2Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
|
4.53 score on a scale
Standard Deviation 7.50
|
5.70 score on a scale
Standard Deviation 7.97
|
PRIMARY outcome
Timeframe: Baseline to Month 1Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=38 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=37 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
|
3.95 score on a scale
Standard Deviation 6.83
|
2.65 score on a scale
Standard Deviation 4.56
|
PRIMARY outcome
Timeframe: Baseline to Month 3Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=37 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=36 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
|
0.97 score on a scale
Standard Deviation 2.32
|
1.28 score on a scale
Standard Deviation 2.21
|
PRIMARY outcome
Timeframe: Baseline to Month 6Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=36 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=35 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
|
0.83 score on a scale
Standard Deviation 1.62
|
0.65 score on a scale
Standard Deviation 2.00
|
PRIMARY outcome
Timeframe: Baseline to Month 12Population: Participants could not be reached by phone at the individual time points, however, this did not disqualify them from future time point calls for the duration of the study. The individual missed time points did not get calculated in the statistical analysis. Two participants were withdrawn at surgery (treatment 1 group).
Change from baseline scores on the dysphagia EAT 10 Screening is a screening tool to help measure swallowing difficulties, dysphagia severity \& monitor treatment response. It is a likert scale from 0-4, with a maximum score of 40. If the EAT-10 score is 3 or higher, this could indicate problems swallowing efficiently or safely.
Outcome measures
| Measure |
Treatment 1; Dexamethasone
n=35 Participants
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=35 Participants
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Change in the Occurrence of Dysphagia - Eating Assessment Tool (EAT 10) Screening.
|
2.09 score on a scale
Standard Deviation 4.86
|
2.44 score on a scale
Standard Deviation 6.66
|
Adverse Events
Treatment 1; Dexamethasone
Treatment 0; Placebo
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment 1; Dexamethasone
n=40 participants at risk
Drug: Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10 and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the single dose steroid administration group or the single dose saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of incision.
Dexamethasone: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
Treatment 0; Placebo
n=38 participants at risk
Drug: Treatment 0; Saline placebo. Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz, EAT 10, and Dysphagia Short Questionnaire will be administered at baseline prior to surgery, Day 1, Day 2, 1 week, 2 weeks, 1 month, 3 months, 6 months, and 12 months after surgery.
Patients will be randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group will receive a single dose, 0.3 mg/kg of body weight of intravenous dexamethasone within one hour of the incision. Patients in the control(saline) group will receive a single dose of saline, 0.3 mg/kg of body weight within one hour of the incision.
Saline: Single dose of Dexamethasone IV or Saline IV given within the first hour of surgery
|
|---|---|---|
|
Surgical and medical procedures
appendix removal
|
0.00%
0/40 • Adverse Events were collected over the year of patient enrollment.
|
2.6%
1/38 • Number of events 1 • Adverse Events were collected over the year of patient enrollment.
|
|
Gastrointestinal disorders
Sore throat
|
0.00%
0/40 • Adverse Events were collected over the year of patient enrollment.
|
10.5%
4/38 • Number of events 4 • Adverse Events were collected over the year of patient enrollment.
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
10.0%
4/40 • Number of events 4 • Adverse Events were collected over the year of patient enrollment.
|
10.5%
4/38 • Number of events 4 • Adverse Events were collected over the year of patient enrollment.
|
|
Cardiac disorders
PE/DVT
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected over the year of patient enrollment.
|
0.00%
0/38 • Adverse Events were collected over the year of patient enrollment.
|
|
Musculoskeletal and connective tissue disorders
joint pain
|
7.5%
3/40 • Number of events 3 • Adverse Events were collected over the year of patient enrollment.
|
5.3%
2/38 • Number of events 2 • Adverse Events were collected over the year of patient enrollment.
|
|
Cardiac disorders
Chest Pain
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected over the year of patient enrollment.
|
5.3%
2/38 • Number of events 2 • Adverse Events were collected over the year of patient enrollment.
|
|
Ear and labyrinth disorders
Dizziness
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected over the year of patient enrollment.
|
2.6%
1/38 • Number of events 1 • Adverse Events were collected over the year of patient enrollment.
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • Number of events 4 • Adverse Events were collected over the year of patient enrollment.
|
5.3%
2/38 • Number of events 2 • Adverse Events were collected over the year of patient enrollment.
|
|
Infections and infestations
Infection
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected over the year of patient enrollment.
|
0.00%
0/38 • Adverse Events were collected over the year of patient enrollment.
|
|
Renal and urinary disorders
Urinary Retention
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected over the year of patient enrollment.
|
0.00%
0/38 • Adverse Events were collected over the year of patient enrollment.
|
|
Skin and subcutaneous tissue disorders
laceration
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected over the year of patient enrollment.
|
2.6%
1/38 • Number of events 1 • Adverse Events were collected over the year of patient enrollment.
|
|
Social circumstances
Falls
|
2.5%
1/40 • Number of events 1 • Adverse Events were collected over the year of patient enrollment.
|
10.5%
4/38 • Number of events 4 • Adverse Events were collected over the year of patient enrollment.
|
|
Surgical and medical procedures
Planned surgical interventions
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected over the year of patient enrollment.
|
7.9%
3/38 • Number of events 3 • Adverse Events were collected over the year of patient enrollment.
|
|
Musculoskeletal and connective tissue disorders
numbness/tingling
|
5.0%
2/40 • Number of events 2 • Adverse Events were collected over the year of patient enrollment.
|
15.8%
6/38 • Number of events 6 • Adverse Events were collected over the year of patient enrollment.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place