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CTRI Number  CTRI/2020/09/027546 [Registered on: 02/09/2020] Trial Registered Prospectively
Last Modified On: 25/08/2021
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   EFFECTIVENESS OF USAGE OF INTRAVENOUS STEROIDS TO REDUCE DIFFICULTY IN SWALLOWING FOLLOWING ANTERIOR CERVICAL SPINE SURGERY: RANDOMISED TRIAL. 
Scientific Title of Study   THE EFFECT OF INTRAVENOUS CORTICOSTEROIDS ON POSTOPERATIVE DYSPHAGIA IN ANTERIOR CERVICAL SPINE SURGERY. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SELVIN PRABHAKAR V 
Designation  F N B SPINE FELLOW 
Affiliation  I NK institute of neuroscience 
Address  NO22 THIRU VI KA STREET NEHRU NAGAR VELACHERY CHENNAI
FLAT GA TOWER 14 SANKALPA 3 ACTION AREA 1 NEWTOWN KOLKATA 700156 WEST BENGAL
Chennai
TAMIL NADU
600042
India 
Phone  9500029431  
Fax    
Email  dr.selvinprabhakar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  ANINDYA BASU 
Designation  CONSULTANT SPINE SURGEON 
Affiliation  I NK institute of neuroscience 
Address  6B 1B BT ROAD KOLKATA

Kolkata
WEST BENGAL
700002
India 
Phone  9830503720  
Fax    
Email  dranindya.basu@gmail.com  
 
Details of Contact Person
Public Query  
Name  SELVIN PRABHAKAR V 
Designation  F N B SPINE FELLOW 
Affiliation  I NK institute of neuroscience 
Address  NO22 THIRU VI KA STREET NEHRU NAGAR VELACHERY CHENNAI
FLAT GA TOWER 14 SANKALPA 3 ACTION AREA 1 NEWTOWN KOLKATA 700156 WEST BENGAL
Chennai
TAMIL NADU
600042
India 
Phone  9500029431  
Fax    
Email  dr.selvinprabhakar@gmail.com  
 
Source of Monetary or Material Support  
I NK institute of neuroscience 
 
Primary Sponsor  
Name  INK institute of neuroscience 
Address  185 Acharya Jagadish Chandra Bose Rd Elgin Kolkata West Bengal 700017 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
selvin prabhakar  I-NK institute of neuroscience  185, Acharya Jagadish Chandra Bose Rd Elgin
Kolkata
WEST BENGAL 		 9500029431

dr.selvinprabhakar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
instittional ethics committe insitute of neurosciences kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G30-G32||Other degenerative diseases of the nervous system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  dexamethasone  3 doses of intravenous dexamethasone will be give one dose immediate pre operative and 2 doses at 8 and 16 hours post operative 
Comparator Agent  normal saline  normal saline given intravenously 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Elective anterior cervical surgery for degenerative cervical disorders.  
 
ExclusionCriteria 
Details  1. Patients scheduled for revision procedures.
2.Those requiring combined anterior and posterior approaches.
3. Patients undergoing surgical procedures for traumatic, neoplastic, or infectious indications.
4. Any patients already receiving or with medical contraindications to systemic corticosteroids.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
POST OPERATIVE DYSPHAGIA COMPARED TO PRE OPERATIVE MEASURED USING EAT 10 SCORE.  PER OPERATIVE
POST OPERATIVE DAY1 DAY2 WEEK1 MONTH1 MONTH2 MONTH4 
 
Secondary Outcome  
Outcome  TimePoints 
POST OPERATIVE DYSPHAGIA COMPARED TO PRE OPERATIVE MEASURED USING BAZAZ SCORE  PER OPERATIVE
POST OPERATIVE DAY1 DAY2 WEEK1 MONTH1 MONTH2 MONTH4 
SWELLING INDEX  POST OPERATIVE DAY 1 MONTH 1 MONTH 2 
JAPANESE ORTHOPAEDIC ASSOCIATION SCORE  PRE OPERATIVE POSTOPERATIVE MONTH 1 MONTH 2 MONTH 4 
NECK DISABILITY INDEX
VISUAL ANALOGUE SCORE 		 PRE OPERATIVE POST OPERATIVE MONTH 1 MONTH2 MONTH4 
 
Target Sample Size   Total Sample Size="64"
Sample Size from India="64" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   07/09/2020 
Date of Study Completion (India) 25/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
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. 
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