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CTRI Number  CTRI/2023/06/053773 [Registered on: 12/06/2023] Trial Registered Prospectively
Last Modified On: 18/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A clinical trial to study the effects of a drug named dexamethasone in reducing postoperative sore throat after gall bladder removal surgery. 
Scientific Title of Study   COMPARISON OF INTRAVENOUS DEXAMETHASONE VERSUS NEBULIZATION WITH DEXAMETHASONE IN REDUCING POST OPERATIVE SORE THROAT IN LAPAROSCOPIC CHOLECYSTECTOMY PATIENTS 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR M SHIVA TEJA 
Designation  POST GRADUATE TRAINEE 
Affiliation  GAUHATI MEDICAL COLLEGE AND HOSPITAL,GUWAHATI 
Address  Department of ANAESTHESIOLOGY AND CRITICAL CARE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI
Department of ANAESTHESIOLOGY AND CRITICAL CARE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI
Kamrup
ASSAM
781032
India 
Phone  8374625546  
Fax    
Email  shivateja508@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DR BANDANA MAHANTA 
Designation  ASSOCIATE PROFESSOR 
Affiliation  GAUHATI MEDICAL COLLEGE AND HOSPITAL,GUWAHATI 
Address  Department of ANAESTHESIOLOGY AND CRITICAL CARE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI
Department of ANAESTHESIOLOGY AND CRITICAL CARE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI
Kamrup
ASSAM
781032
India 
Phone  7399063633  
Fax    
Email  drbandana.mahanta1964@gmail.com  
 
Details of Contact Person
Public Query
 
Name  DR M SHIVA TEJA 
Designation  POST GRADUATE TRAINEE 
Affiliation  GAUHATI MEDICAL COLLEGE AND HOSPITAL,GUWAHATI 
Address  Department of ANAESTHESIOLOGY AND CRITICAL CARE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI
Department of ANAESTHESIOLOGY AND CRITICAL CARE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI
Kamrup
ASSAM
781032
India 
Phone  8374625546  
Fax    
Email  shivateja508@gmail.com  
 
Source of Monetary or Material Support  
GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI,KAMRUP METRO,ASSAM 781032 
 
Primary Sponsor  
Name  DR M SHIVA TEJA 
Address  POST GRADUATE TRAINEE,Department of ANAESTHESIOLOGY AND CRITICAL CARE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI,ASSAM 
Type of Sponsor  Other [SELF] 
 
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 
DR M SHIVA TEJA  GAUHATI MEDICAL COLLEGE AND HOSPITAL,GUWAHATI  Department of ANAESTHESIOLOGY AND CRITICAL CARE,GAUHATI MEDICAL COLLEGE AND HOSPITAL,BHANGAGARH,GUWAHATI
Kamrup
ASSAM 
8374625546

shivateja508@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE,GAUHATI MEDICAL COLLEGE AND HOSPITAL  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  DEXAMETHASONE INTRAVENOUS ROUTE  8MG(2ml )of inj.dexamethasone will be administered to patient via i.v route 30 minutes prior to general anaesthesia 
Comparator Agent  DEXAMETHASONE VIA NEBULIZATION  8MG(2ml)of inj.dexamethasone will be given to patient via nebulization 30 minutes prior to general anaesthesia 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.ASA classification 1 & 2
2.All genders
3.Patients posted for elective laparoscopic cholecystectomy uder general anaesthesia with endotracheal intubation.
4.Duration of surgery less than 2 hours
5.Patients willing to give informed and written consent 
 
ExclusionCriteria 
Details  1.history of allergic reactions to DEXAMETHASONE.
2.Patients on steroids already.
3.patients with anticipated difficult intubation.
4.Patients who would require manipulation or instrumentation of airway.
5.patients who need second attempt during ET tube insertion.
6.Patients with sore throat/URTI/hoarseness.
7.patients with Cormack Lehane grade 4. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the post operative sore throat (POST) incidence between two groups in first 24 hours  at 1hr,6hr,12hr,24 hours after surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.To compare the incidence of hoarseness & grade of hoarseness between two groups
2.To compare the incidence of postoperative nausea & vomiting (PONV)between two groups 
at 1hr,6hr,12hr,24 hours after surgery 
 
Target Sample Size   Total Sample Size="214"
Sample Size from India="214" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/07/2023 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details
Modification(s)  
None yet 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Postoperative sore throat(POST) is common after endotracheal intubation making the  patients uncomfortable and anxious in post operative period. POST is a common complication after general anaesthesia. Though considered to be a minor complication by most of the clinicians it may be quite distressing for the patient.Post operative sore throat results in cough.Cough after any surgery causes strains at the suture site increasing pain at the  site of surgery and thus further adding to patients discomfort and dissatisfaction.It also adds to patients morbidity and making post operative period a bad memory for the patient. Hoarseness is also known to occur after endotracheal intubation. This change in voice may range from mild hoarseness noted by the patient to complete aphonia.


PROCEDURE: After hospital ethical committee approval patients who are satisfying the inclusion criteria will be selected after prior pre-anaesthetic check up.   Patients will be randomly assigned into two equal groups,i.e,GROUP N and GROUP I using computer generated random sequencing software and provided to an assistant in sealed opaque envelopes. 

  GROUP N: They will receive 2 ml(8 mg) DEXAMETHASONE  nebulisation and 2 ml 0.9 % saline intravenously.

GROUP I: They will receive 2 ml (8 MG) OF i.v DEXAMETHASONE  and nebulisation with 2 ml 0.9 % NACL

The drug volume in both the group will be the same ( nebulisation/intravenous).

Before 30 minutes of commencement of surgery , the patient in group N  will be nebulised with 2 ml of dexamethasone and 2 ml 0.9% NACL given intravenously and viceversa in group I by the assistant.

After the OT patient shifted to PACU where  PR BP RR SPO2  monitored for 24 hours where incidence of POST,PONV,HOARSENESS will be recorded at 1hr,6hr,12hr,24hr postoperatively.

 
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