| CTRI Number |
CTRI/2026/01/100908 [Registered on: 12/01/2026] Trial Registered Prospectively |
| Last Modified On: |
07/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Which drug is better for nebulization either ropovacaine or ketamine before intubation and after extubation |
|
Scientific Title of Study
|
Comparison of the effect of nebulization with ropivacaine versus nebulization with ketamine on hemodynamic response and postoperative sore throat in patient undergoing surgery under general anaesthesia- a randomized controlled trial |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Afridbasha S |
| Designation |
PG resident |
| Affiliation |
Dr S N Medical College jodhpur |
| Address |
Department of Anaesthesiology
Dr S N Medical College jodhpur
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9655131620 |
| Fax |
|
| Email |
afridbasha24@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Monika Gupta |
| Designation |
Associate Professor |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Department of Anaesthesiology,Dr S N Medical College, Jodhpur, Rajasthan 342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9414377221 |
| Fax |
|
| Email |
moniks111@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Monika Gupta |
| Designation |
Associate Professor |
| Affiliation |
Dr S N Medical College, Jodhpur |
| Address |
Department of Anaesthesiology,Dr S N Medical College, Jodhpur, Rajasthan 342001
Jodhpur
RAJASTHAN
342001
India |
| Phone |
9414377221 |
| Fax |
|
| Email |
moniks111@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr S N Medical College, Jodhpur |
|
|
Primary Sponsor
|
| Name |
Dr S N Medical College, Jodhpur |
| Address |
Dr S N Medical College, Shastri Nagar, Residency road, Jodhpur,Rajasthan 342001 |
| 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 |
| Afridbasha S |
Mathuradas Mathur hospital |
Trauma operation theatre, Department of Anaesthesiology, Dr S N Medical College,Jodhpur,Rajasthan
Jodhpur
RAJASTHAN |
9655131620
afridbasha24@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr Sampurnanand Medical College Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nebulization with ketamine group |
1mg/kg mixed with normal saline to make total volume of 5ml |
| Comparator Agent |
Nebulization with ropivacine |
0.75% ropivacaine , total volume of 5ml |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and 2,single attempt of intubation within 15 seconds,elective surgery under 2hours of duration |
|
| ExclusionCriteria |
| Details |
Allergy to study drugs,respiratory disease,pregnancy and lactation, |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Hemodynamic response after intubation |
Before nebulization,immediately after intubation,5 minutes after intubation,post extubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Postoperative sore throat |
5 minutes After extubation,6hours after extubation, |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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 4 |
|
Date of First Enrollment (India)
|
25/01/2026 |
| 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="0"
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
|
The aim to compare hemodynamic response in patients undergoing general anaesthesia and post operative sore throat by using the nebulization with ropivacaine versus nebulization with ketamine primaryoutcome-to compare hemodynamic response secondary outcome-post operative sore throat |