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
|
|
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
|
|
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. |