Trial Outcomes & Findings for Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery (NCT NCT02266797)
NCT ID: NCT02266797
Last Updated: 2018-10-25
Results Overview
The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.
TERMINATED
PHASE3
4 participants
12 months
2018-10-25
Participant Flow
Participant milestones
| Measure |
Dexamethasone
Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
|
Saline
Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
3
|
|
Overall Study
COMPLETED
|
1
|
2
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Intravenous Corticosteroid Injections on Dysphagia After Cervical Spine Surgery
Baseline characteristics by cohort
| Measure |
Dexamethasone
n=1 Participants
Subject will receive doses of intravenous dexamethasone, a corticosteroid. The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
Dexamethasone: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose. Dexamethasone doses will be 0.3 mg/kg for the first dose and 0.15 mg/kg for each subsequent dose.
|
Saline
n=3 Participants
Subject will receive doses of intravenous physiological saline solution.
Saline: The first dose will be given before the incision and the subsequent doses will be given 8 and 16 hours after the first dose.
|
Total
n=4 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
3 participants
n=107 Participants
|
4 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data not available due to premature halting of study
The severity of dysphagia will be evaluated by dysphagia questionnaires and a two week postoperative swallow evaluation by a licensed swallowing expert. If recommended by the swallow evaluation, a videofluoroscopic swallow study (VFSS) will be performed to further evaluate the severity of dysphagia.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 12 monthsPopulation: Data not available due to premature halting of study
Soft-tissue swelling will be measured by the anterior cervical soft-tissue shadow width on lateral cervical radiographs. The extent of dysphagia will be evaluated by the dysphagia questionnaires, the swallow evaluation, and the VFSS, if necessary.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not available due to premature halting of study
Aspiration rates will be evaluated by the percentage of patients in each group with post-operative aspiration.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Immediate post-operativelyPopulation: Data not available due to premature halting of study
This will be quantified by the visual analogue scale (VAS) questionnaire for nausea and measuring the number of vomiting episodes following surgery.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not available due to premature halting of study
This will be quantified by the NDI questionnaire and VAS questionnaire for neck pain and arm pain.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: Data not available due to premature halting of study
The outcomes of surgery will be examined through the 1 year post-operative appointment.
Outcome measures
Outcome data not reported
Adverse Events
Dexamethasone
Saline
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place