THE EFFECT OF INTRAVENOUS CORTICOSTEROIDS ON POSTOPERATIVE DYSPHAGIA IN ANTERIOR CERVICAL SPINE SURGERY.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 64
- Locations
- 1
- Primary Endpoint
- POST OPERATIVE DYSPHAGIA COMPARED TO PRE OPERATIVE MEASURED USING EAT 10 SCORE.
Study Overview
Brief Summary
Aim of the study is to study effect of interavenous corticosteroid administration perioperatively during anterior cervical surgery on post operative dysphagia which will be measured primarily using EAT-10 score. Secondary indices like Bazaz scale, Swelling index, Japanese orthopaedic association score, Neck Disability Index questionnaire score and a visual analogue scale are also noted pre and post operatively. study will be parallel group, randomized, placebo controlled, triple blinded study. The patients will be randomized into 2 groups, study group will be getting corticosteroid and control group will be getting placebo (normal saline). At the end of study the difference in various parameters recorded between the two groups and there statistical significance will be studied.
Study Design
- Study Type
- Interventional
- Allocation
- Computer generated randomization
- Masking
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Eligibility Criteria
- Ages
- 18.00 Year(s) to 90.00 Year(s) (—)
- Sex
- All
Inclusion Criteria
- •Elective anterior cervical surgery for degenerative cervical disorders.
Exclusion Criteria
- •Patients scheduled for revision procedures.
- •2.Those requiring combined anterior and posterior approaches.
- •Patients undergoing surgical procedures for traumatic, neoplastic, or infectious indications.
- •Any patients already receiving or with medical contraindications to systemic corticosteroids.
Outcomes
Primary Outcomes
POST OPERATIVE DYSPHAGIA COMPARED TO PRE OPERATIVE MEASURED USING EAT 10 SCORE.
Time Frame: PER OPERATIVE | POST OPERATIVE DAY1 DAY2 WEEK1 MONTH1 MONTH2 MONTH4
Secondary Outcomes
- POST OPERATIVE DYSPHAGIA COMPARED TO PRE OPERATIVE MEASURED USING BAZAZ SCORE(PER OPERATIVE)
- NECK DISABILITY INDEX(VISUAL ANALOGUE SCORE)
- SWELLING INDEX(POST OPERATIVE DAY 1 MONTH 1 MONTH 2)
- JAPANESE ORTHOPAEDIC ASSOCIATION SCORE(PRE OPERATIVE POSTOPERATIVE MONTH 1 MONTH 2 MONTH 4)