Dysphagia
Conditions
Brief summary
This prospective, randomized, double blind, controlled study evaluates the effect of perioperative IV steroids versus saline on swallowing after anterior cervical spine surgery.
Detailed description
This investigation is a prospective, randomized, double-blind, controlled trial testing peri-operative steroids versus saline and the effect on swallowing after anterior cervical spine surgery. Swallowing symptoms will be measured using the patient reported Bazaz (Bazaz) scale and the Dysphagia Short Questionnaire (DSQ). Swallowing data will be obtained pre-operatively, one day and two days post-operatively and then one week, two weeks, four weeks, three months, six months, and one year post-operatively. Patient clinical outcomes will be captured using web-based progress reports. Patients will complete the Quality of Life (QoL-12), Neck Disability Index (NDI), and Visual Analog Scale (VAS) questionnaires electronically pre-operatively and at one year post-operatively. This outcome data will help us analyze the swallowing function or symptoms with the overall clinical course of the patients enrolled in this study.
Interventions
DRUGTreatment 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.
DRUGTreatment 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.
Sponsors
West Virginia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Elective anterior approach to subaxial cervical spine (C3 - T1); * ages 18-80
Exclusion criteria
* Traumatic or tumor etiologies * undergoing anterior-posterior operations * neoplastic, or infectious conditions requiring surgery * a history of previous anterior cervical spine surgery * any patient requiring a halo vest * patients on chronic steroids * patients remaining intubated post-operatively (please see more under risks below) * less than 18 years of age * pregnant women * no phone
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Swallowing Difficulty | 1 day; 2 days; 1 week; 2 weeks; 1 month; 3 months; 6 months;12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline and 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. |
| Fusion Rate Steroid vs Placebo | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Treatment 1; Dexamethasone 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. | 33 |
| Treatment 0; Saline Placebo 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. | 31 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | given steroids | 1 | 2 |
| Overall Study | Lost to Follow-up | 0 | 2 |
| Overall Study | Protocol Violation | 0 | 1 |
| Overall Study | recruited during continuing renewal proc | 0 | 1 |
| Overall Study | re-operation | 1 | 0 |
| Overall Study | surgery started late | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Treatment 1; Dexamethasone | Treatment 0; Saline Placebo | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 3 Participants | 0 Participants | 3 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 31 Participants | 61 Participants |
| Region of Enrollment United States | 33 participants | 31 participants | 64 participants |
| Sex: Female, Male Female | 20 Participants | 16 Participants | 36 Participants |
| Sex: Female, Male Male | 13 Participants | 15 Participants | 28 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 0 / 31 |
| other Total, other adverse events | 0 / 33 | 0 / 31 |
| serious Total, serious adverse events | 0 / 33 | 0 / 31 |
Outcome results
Primary
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 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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing Month 3 | 9 Participants |
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing Month 1 | 19 Participants |
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing Month 12 | 11 Participants |
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing Week 1 | 29 Participants |
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing day 2 | 22 Participants |
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing day 1 | 24 Participants |
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing Month 6 | 6 Participants |
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing Week 2 | 23 Participants |
| Dexamethasone DSQ | Swallowing Difficulty | Difficulty swallowing Baseline | 16 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing Week 2 | 27 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing Month 3 | 17 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing Month 1 | 24 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing day 1 | 28 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing Baseline | 14 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing day 2 | 28 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing Month 12 | 13 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing Month 6 | 11 Participants |
| Saline Placebo DSQ | Swallowing Difficulty | Difficulty swallowing Week 1 | 28 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing Week 2 | 14 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing Baseline | 5 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing day 1 | 19 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing day 2 | 15 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing Week 1 | 14 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing Month 1 | 13 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing Month 3 | 3 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing Month 6 | 2 Participants |
| Dexamethasone Bazaz | Swallowing Difficulty | Difficulty swallowing Month 12 | 7 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing Month 3 | 11 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing Week 1 | 21 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing day 2 | 23 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing Month 12 | 8 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing Month 6 | 10 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing day 1 | 21 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing Month 1 | 17 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing Week 2 | 19 Participants |
| Saline Placebo Bazaz | Swallowing Difficulty | Difficulty swallowing Baseline | 7 Participants |
Comparison: Comparing DSQ between Dexamethasone and Saline at Day 1 post-opp-value: 0.03695% CI: [-2.9761, -0.1022]t-test, 2 sided
Comparison: Comparing Bazaz between Dexamethasone and Saline at 6 months post-opp-value: <0.0595% CI: [-1.1151, -0.093]t-test, 2 sided
Secondary
Change in Quality of Life
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.
Time frame: 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.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexamethasone DSQ | Change in Quality of Life | -6.1208 units on a scale | Standard Error 3.1273 |
| Saline Placebo DSQ | Change in Quality of Life | -7.9082 units on a scale | Standard Error 3.1273 |
Comparison: Comparing the changes in VNDI between Dexamethasone and Saline from baseline to last visitp-value: <0.0595% CI: [-4.5153, 8.0902]t-test, 2 sided
Secondary
Fusion Rate Steroid vs Placebo
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.
Time frame: 1 year
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexamethasone DSQ | Fusion Rate Steroid vs Placebo | unknown | 13 Participants |
| Dexamethasone DSQ | Fusion Rate Steroid vs Placebo | fused | 20 Participants |
| Dexamethasone DSQ | Fusion Rate Steroid vs Placebo | not fused | 0 Participants |
| Saline Placebo DSQ | Fusion Rate Steroid vs Placebo | unknown | 19 Participants |
| Saline Placebo DSQ | Fusion Rate Steroid vs Placebo | fused | 11 Participants |
| Saline Placebo DSQ | Fusion Rate Steroid vs Placebo | not fused | 1 Participants |
p-value: 0.375Fisher Exact