| CTRI Number |
CTRI/2024/08/071899 [Registered on: 05/08/2024] Trial Registered Prospectively |
| Last Modified On: |
03/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the effect of two drugs Dexmedetomidine and Dexamethasone on decreasing the postoperative sore throat. |
|
Scientific Title of Study
|
Efficacy of Dexmedetomidine and Dexamethasone gargle on postoperative sore throat: A randomized double blind clinical study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohammad Ehtsham |
| Designation |
Junior Resident |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of Anaeasthesiology and critical care UPUMS Saifai, Etawah,UTTAR PRADESH
Etawah
UTTAR PRADESH
206130
India |
| Phone |
8052112236 |
| Fax |
|
| Email |
mohdehtsham600@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Jay Brijesh Singh Yadav |
| Designation |
Associate Professor |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of Anaeasthesiology and critical care UPUMS Saifai, Etawah,UTTAR PRADESH
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9368177577 |
| Fax |
|
| Email |
drjaybrijesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Jay Brijesh Singh Yadav |
| Designation |
Associate Professor |
| Affiliation |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
| Address |
Department of Anaeasthesiology and critical care UPUMS Saifai, Etawah,UTTAR PRADESH
Etawah
UTTAR PRADESH
206130
India |
| Phone |
9368177577 |
| Fax |
|
| Email |
drjaybrijesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and critical care, room 329, (Uttar pradesh university of medical science), Etawah, Uttar Pradesh, India (pin code - 206130) |
|
|
Primary Sponsor
|
| Name |
Uttar Pradesh university of medical sciences |
| Address |
Department of Anaesthesiology and critical care, room 329, (Uttar Pradesh university of medical science), Etawah, Uttar Pradesh, India (pin code - 206130) |
| Type of Sponsor |
Government medical college |
|
|
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 Mohammad Ehtsham |
UTTAR PRADESH UNIVERSITY OF MEDICAL SCIENCES |
Department of Anaesthesiology and critical care UPUMS Saifai Etawah UTTAR PRADESH
Etawah
UTTAR PRADESH |
8052112236
mohdehtsham600@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Uttar Pradesh University of Medical Sciences |
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 |
| Comparator Agent |
Dexamethasone |
25 ml solution of gargle of Dexamethasone(.1 mg/kg) diluted with .9% normal saline will be given to group(B) patients by oral rout 5 minute before the induction of anaesthesia for 10 seconds.
|
| Intervention |
Dexmedetomidine |
25 ml solution of gargle of dexmedetomidine(.5 microgram/kg) diluted with .9% normal saline will be given to group(A) patients by oral rout 5 minute before the induction of anaesthesia for 10 seconds.
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients age: 20 to 45 years.
Patients of ASA Physical Status classification I and II.
Patients requiring endotracheal intubation in laparoscopic cholecystectomy. |
|
| ExclusionCriteria |
| Details |
Preoperative sore throat.
Patients with history of recent upper respiratory tract infection.
Chronic smokers.
History of allergy to study drugs.
Intubation unsuccessful in first attempt.
Pregnant patients. |
|
|
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 |
| The sore throat and cough will be assessed by interviewing the patients. |
Immediately after extubation.
After 2 hour in post anaersthesia care unit.
After 6 hour in post anaesthesia care unit.
After 12 hour in post anaesthesia care unit.
After 24 hour in post anaesthesia care unit. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the severity of cough in grougs.
To compare the perioperative hemodynamic parameters
To compare the complication ,if any |
Before the intubation
Immediately after the extubation
At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes. |
To compare the severity of cough in grougs.
To compare the perioperative hemodynamic parameters
To compare the complication ,if any |
Before the intubation
Immediately after the extubation
At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes. |
To compare the severity of cough in grougs.
To compare the perioperative hemodynamic parameters
To compare the complication ,if any |
Before the intubation
Immediately after the extubation
At 15 minutes, 30 minutes, 45 minutes, 60 minutes, 75 minutes. |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
30/08/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
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 a common post operative complication that occurs in14.4% to 73.9% in patient who undergo general anaesthesia with endotracheal intubation. Causes of postoperative sore throat are known to be associated with inflammation and stimulation by endotracheal intubation. The pharmacological methods that have been found to be effective in decreasing the incidence and severity of post operative sore throat include preoperative gargling with ketamine and magnesium solution, intravenous injection of dexamethasone, gargling and tube soaking with dexamethasone. Dexmedetomidine, a selective alpha-2 receptor agonist, is also administered for short term sedation in pediatric procedures and in icu, cardiac surgeries to decrease sympathetic tone, bariatric surgeries as it causes less respiratory depression. Though the effect of dexamethasone nebulization and gargle on post operative sore throat has been studied, the literature on the role of dexmedetomidine gargle is sparse. We are hypothesizing that preoperative gargle with dexmedetomidine will reduce the incidence and severity of post operative sore throat more effectively than gargle with dexamethasone. Hence this study is designed to compare the effectiveness of preoperative gargle of dexamethasone, dexmedetomidine in reducing the severity of post operative sore throat in patients undergoing endotracheal intubation. |