| CTRI Number |
CTRI/2024/09/073816 [Registered on: 12/09/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia
Preventive |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Comparison of dexmedetomidine, ketamine & magnesium sulphate nebulisation in preventing post operative sore throat |
|
Scientific Title of Study
|
A Comparative Study Of Preoperative Dexmedetomidine , Ketamine & Magnesium Sulphate Nebulisation For Incidence Of Postoperative Sore Throat After Endotracheal Intubation. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR NAVEEN MALHOTRA |
| Designation |
Prof & Head Of Department |
| Affiliation |
N.C. MEDICAL COLLEGE &HOSPITAL , ISRANA PANIPAT |
| Address |
Department of Anaesthesiology and Critical Care
N.C. MEDICAL COLLEGE & HOSPITAL
ISRANA , PANIPAT
N.C. MEDICAL COLLEGE &HOSPITAL , ISRANA , PANIPAT
Panipat
HARYANA
132103
India |
| Phone |
9812091051 |
| Fax |
|
| Email |
drnaveenmalhotra@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MUSKAN |
| Designation |
PG 1st Year Student |
| Affiliation |
N.C. MEDICAL COLLEGE & HOSPITAL , ISRANA , PANIPAT |
| Address |
Department of Anaesthesiology and Critical Care
Main OT Complex , Third Floor
N.C. MEDICAL COLLEGE & HOSPITAL , ISRANA , PANIPAT, HARYANA
Panipat
HARYANA
132107
India |
| Phone |
8222814101 |
| Fax |
|
| Email |
muskanpanwar1501@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MUSKAN |
| Designation |
PG 1st Year Student |
| Affiliation |
N.C. MEDICAL COLLEGE & HOSPITAL , ISRANA , PANIPAT |
| Address |
Department of Anaesthesiology and Critical Care
Main OT Complex , Third Floor
N.C. MEDICAL COLLEGE & HOSPITAL , ISRANA , PANIPAT , HARYANA
Panipat
HARYANA
132107
India |
| Phone |
8222814101 |
| Fax |
|
| Email |
muskanpanwar1501@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical care, NC Medical College
Israna,Panipat , India (132107) |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology and Critical Care |
| Address |
N.C. MEDICAL COLLEGE & HOSPITAL , ISRANA , PANIPAT , India
132107 |
| Type of Sponsor |
Private 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 Muskan |
N.C. Medical College |
Department of Anaesthesiology and critical care
3 floor , OT Complex
Panipat
HARYANA |
8222814101
1
mukanpanwar1501@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee NC 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 |
| Comparator Agent |
Dexmedetomidine |
Dexmedetomidine 50 micrograms with 4ml saline |
| Comparator Agent |
KETAMINE |
Ketamine 50 mg (1 ml ) with 4 ml saline |
| Comparator Agent |
Magnesium Sulphate |
Magnesium Sulphate 2ml 50% w/v |
| Intervention |
Nebulisation |
Ketamine 50mg (1ml) with 4ml saline
Dexmedetomidine 50 micrograms 4ml saline
Magnesium sulphate 2ml 50% w/v
( for time duration of 15 minutes) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
All subjects scheduled for elective operations requiring general anaesthesia and tracheal intubation .
ASA grade I , II .
Mallampatti grading I , II
|
|
| ExclusionCriteria |
| Details |
Patients with history of sore throat
Mallampati grading III , IV
H/O Drug Allergy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The primary aim is to investigate the impact of nebulisation with ketamine , magnesium sulphate and dexmedetomidine on incidence of postoperative sore throat following endotracheal intubation |
To evaluate sore throat in patients after extubation at 0 hours,2 hour,4 hours,8 hours ,12 hours , 24 hours |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the severity of post operative sore throat in patients treated with each of these nebulization agents. |
To evaluate sore throat in patients after extubation at 0 hours,2 hours, 4hours , 8 hours, 12 hours ,24 hours |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
Final Enrollment numbers achieved (Total)= "150"
Final Enrollment numbers achieved (India)="150" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/10/2024 |
| Date of Study Completion (India) |
01/01/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
01/01/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Post Operative Sore Throat is a common post operative complication in patients undergoing General anaesthesia with endotracheal intubation. This study aims to minimise the incidence of sore throat by preoperative nebulisation with dexmedetomidine, ketamine and magnesium sulphate.
Study has been completed. |