Trial Outcomes & Findings for Dysphagia Following Anterior Cervical Spine Surgery; Steroid vs Saline (NCT NCT02416934)

Last Updated: 2019-02-05

Results Overview

Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score of zero indicates no symptoms. Any number above zero indicates difficulty swallowing. The Bazaz score of Zero indicates no symptoms. Any number above zero indicates difficulty swallowing. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are listed below associated with the randomization assignment and survey used.

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months

Results posted on

2019-02-05

Participant Flow

Potential participants undergoing elective anterior cervical spine surgery will be seen by spine surgeons at the WVU Spine Center. Participants will be told about the study and given the opportunity to consent. Consented participants will be randomized to either the steroid administration group or the saline administration group.

Participant milestones

Participant milestones
Measure	Treatment 1; Dexamethasone Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 1; Dexamethasone	Treatment 0; Saline Placebo Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 0; Saline placebo
Overall Study STARTED	36	38
Overall Study Double Blind (0-52 Weeks)	36	38
Overall Study Last Participant Completed 1 yr	33	31
Overall Study COMPLETED	33	31
Overall Study NOT COMPLETED	3	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment 1; Dexamethasone Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 1; Dexamethasone	Treatment 0; Saline Placebo Swallowing difficulty at various time points as measured by the DSQ and Bazaz for subjects randomized to Treatment 0; Saline placebo
Overall Study given steroids	1	2
Overall Study Lost to Follow-up	0	2
Overall Study Withdrawal by Subject	1	0
Overall Study recruited during continuing renewal proc	0	1
Overall Study Protocol Violation	0	1
Overall Study surgery started late	0	1
Overall Study re-operation	1	0

Baseline Characteristics

Ten total subjects were removed from the study for various reasons.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment 1; Dexamethasone n=33 Participants Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz 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 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Treatment 0; Saline Placebo n=31 Participants Patients undergoing elective anterior cervical spine surgery will be seen by spine surgeons. After consent the Bazaz 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 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Patients in the control(saline) group will receive a similar volume of saline on the same schedule for three doses. Treatment 0; Saline placebo: Saline (placebo) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Total n=64 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=99 Participants • Ten total subjects were removed from the study for various reasons.	0 Participants n=107 Participants • Ten total subjects were removed from the study for various reasons.	0 Participants n=206 Participants • Ten total subjects were removed from the study for various reasons.
Age, Categorical Between 18 and 65 years	30 Participants n=99 Participants • Ten total subjects were removed from the study for various reasons.	31 Participants n=107 Participants • Ten total subjects were removed from the study for various reasons.	61 Participants n=206 Participants • Ten total subjects were removed from the study for various reasons.
Age, Categorical >=65 years	3 Participants n=99 Participants • Ten total subjects were removed from the study for various reasons.	0 Participants n=107 Participants • Ten total subjects were removed from the study for various reasons.	3 Participants n=206 Participants • Ten total subjects were removed from the study for various reasons.
Sex: Female, Male Female	20 Participants n=99 Participants	16 Participants n=107 Participants	36 Participants n=206 Participants
Sex: Female, Male Male	13 Participants n=99 Participants	15 Participants n=107 Participants	28 Participants n=206 Participants
Region of Enrollment United States	33 participants n=99 Participants	31 participants n=107 Participants	64 participants n=206 Participants

PRIMARY outcome

Timeframe: 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months

Population: Treatment 1; Dexamethasone or Treatment 0; Saline placebo. Treatment 1 received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. Dosage was approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 0 received similar volume of saline on same schedule for three doses.

Outcome measures

Outcome measures
Measure	Dexamethasone DSQ n=33 Participants Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Saline Placebo DSQ n=31 Participants Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline. Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Dexamethasone Bazaz n=33 Participants Treatment 1; Dexamethasone. Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Saline Placebo Bazaz n=31 Participants Treatment 0; Saline Placebo. Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline. Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
Swallowing Difficulty Difficulty swallowing day 1	24 Participants	28 Participants	19 Participants	21 Participants
Swallowing Difficulty Difficulty swallowing Baseline	16 Participants	14 Participants	5 Participants	7 Participants
Swallowing Difficulty Difficulty swallowing day 2	22 Participants	28 Participants	15 Participants	23 Participants
Swallowing Difficulty Difficulty swallowing Week 1	29 Participants	28 Participants	14 Participants	21 Participants
Swallowing Difficulty Difficulty swallowing Week 2	23 Participants	27 Participants	14 Participants	19 Participants
Swallowing Difficulty Difficulty swallowing Month 1	19 Participants	24 Participants	13 Participants	17 Participants
Swallowing Difficulty Difficulty swallowing Month 3	9 Participants	17 Participants	3 Participants	11 Participants
Swallowing Difficulty Difficulty swallowing Month 6	6 Participants	11 Participants	2 Participants	10 Participants
Swallowing Difficulty Difficulty swallowing Month 12	11 Participants	13 Participants	7 Participants	8 Participants

SECONDARY outcome

Timeframe: Baseline and 1 year (or last visit as appropriate). Not all subjects followed up at 1 year.

Population: Neck Disability Index change from baseline to 1 year or last visit as appropriate. Not all subjects followed up at 1 year.

Change in Quality of life measured by the Neck Disability Index (NDI) from baseline and 1 year for Treatment 1; Dexamethasone and Treatment 0; Saline placebo. The NDI measures self-rated disability due to neck pain. Each of the 10 items is scored from 0 - 5. The maximum score is 50. The higher the score the more disability. The scale is 0 - 4 = no disability; 5 - 14 = mild;15 - 24 = moderate; 25 - 34 = severe; above 34 = complete disability.

Outcome measures

Outcome measures
Measure	Dexamethasone DSQ n=33 Participants Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Saline Placebo DSQ n=31 Participants Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline. Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Dexamethasone Bazaz Treatment 1; Dexamethasone. Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Saline Placebo Bazaz Treatment 0; Saline Placebo. Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline. Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
Change in Quality of Life	-6.1208 units on a scale Standard Error 3.1273	-7.9082 units on a scale Standard Error 3.1273	—	—

SECONDARY outcome

Timeframe: 1 year

Participants were considered fused if radiographs demonstrated less than 1 millimeter of interspinous motion between flexion and extension,7 or if CT/MRI demonstrated clear evidence of bone bridging from endplate to endplate.

Outcome measures

Outcome measures
Measure	Dexamethasone DSQ n=33 Participants Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Saline Placebo DSQ n=31 Participants Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline. Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Dexamethasone Bazaz Treatment 1; Dexamethasone. Treatment 1; Dexamethasone. Patients undergoing elective anterior cervical spine surgery were seen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the experimental (steroid) group received 0.3 mg/kg of intravenous dexamethasone within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of dexamethasone. Treatment 1; Dexamethasone: Dexamethasone IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.	Saline Placebo Bazaz Treatment 0; Saline Placebo. Treatment 0; Saline Placebo. Patients undergoing elective anterior cervical spine surgery wereseen by spine surgeons. After consent the Bazaz and Dysphagia Short Questionnaire were 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 were randomized to either the steroid administration group or the saline administration group. Patients randomized to the control (saline) group received 0.3 mg/kg of intravenous saline within one hour of the incision, then 0.15 mg/kg every eight hours for two doses. This dosage is approximately 20 mg, 10 mg, and 10 mg of saline. Treatment 0; Control (Saline) IV given within the first hour of surgery; second dose given 8 hours after first dose; third dose given 8 hours after second dose.
Fusion Rate Steroid vs Placebo unknown	13 Participants	19 Participants	—	—
Fusion Rate Steroid vs Placebo fused	20 Participants	11 Participants	—	—
Fusion Rate Steroid vs Placebo not fused	0 Participants	1 Participants	—	—

Adverse Events

Treatment 1; Dexamethasone

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment 0; Saline Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Treatment 1; Dexamethasone n=33 participants at risk Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.	Treatment 0; Saline Placebo n=31 participants at risk Swallowing difficulty. Two measurement surveys were used: The Dysphagia Short Questionnaire: An Instrument for Evaluation of Dysphagia (DSQ) and Bazaz Dysphagia Scale (Bazaz). The DSQ and Bazaz determine levels of dysphagia over time after anterior cervical spine surgery. A DSQ score is calculated by summing up the points given for each item to a maximum of 18 points, where lower scores represent milder symptoms (zero indicates no symptoms) and vice versa. For the Bazaz score, symptoms are measured as 'none', 'mild', 'moderate', or 'severe'. Zero indicates none or no symptoms, 1 indicates mild, 2 indicates moderate, 3 indicates severe. Numbers of subjects reporting any difficulty swallowing (had to have a score of at least 1) at various time points are reported.
Surgical and medical procedures intraoperative musculoskeletal injury	0.00% 0/33 • up to 1 year Other not including serious adverse events	0.00% 0/31 • up to 1 year Other not including serious adverse events
Surgical and medical procedures intraoperative neurological injury	0.00% 0/33 • up to 1 year Other not including serious adverse events	0.00% 0/31 • up to 1 year Other not including serious adverse events

Other adverse events

Adverse event data not reported

Additional Information

Dr. Sanford Emery

West Virginia University Department of Orthopaedics

Phone: 304-293-1170

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place