EFFECTIVENESS OF USAGE OF INTRAVENOUS STEROIDS TO REDUCE DIFFICULTY IN SWALLOWING FOLLOWING ANTERIOR CERVICAL SPINE SURGERY: RANDOMISED TRIAL.

Completed

• Conditions: Other degenerative diseases of the nervous system,

• Registration Number: CTRI/2020/09/027546
• Lead Sponsor: INK institute of neuroscience

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-07-09
• Study Completion: 2021-08-25
• Last Update Posted: 2021-08-25

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 64

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
POST OPERATIVE DYSPHAGIA COMPARED TO PRE OPERATIVE MEASURED USING EAT 10 SCORE.	PER OPERATIVE | POST OPERATIVE DAY1 DAY2 WEEK1 MONTH1 MONTH2 MONTH4

Secondary Outcome Measures

Name	Time	Method
NECK DISABILITY INDEX	VISUAL ANALOGUE SCORE
POST OPERATIVE DYSPHAGIA COMPARED TO PRE OPERATIVE MEASURED USING BAZAZ SCORE	PER OPERATIVE
SWELLING INDEX	POST OPERATIVE DAY 1 MONTH 1 MONTH 2
JAPANESE ORTHOPAEDIC ASSOCIATION SCORE	PRE OPERATIVE POSTOPERATIVE MONTH 1 MONTH 2 MONTH 4

Trial Locations

Locations (1)

I-NK institute of neuroscience; 🇮🇳 Kolkata, WEST BENGAL, India

I-NK institute of neuroscience

🇮🇳Kolkata, WEST BENGAL, India

selvin prabhakar

Principal investigator

9500029431

dr.selvinprabhakar@gmail.com