| CTRI Number |
CTRI/2025/12/099296 [Registered on: 17/12/2025] Trial Registered Prospectively |
| Last Modified On: |
16/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
A Study Comparing Three Drugs Intravenous Lignocaine Versus Labetalol Versus EsmololOn Heart Rate And Blood Pressure During Intubation In Surgery. |
|
Scientific Title of Study
|
A Randomised Comparative Study To Compare Efficacy Of Intravenous Lignocaine Versus Labetalol Versus Esmolol For Attenuating The Haemodynamic Response To Laryngoscopy And Endotracheal Intubation At S.M.S Medical College Jaipur. |
| 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 Sunil Chauhan |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Departmet Of Anaesthesiology SMS Medical College And Hospital Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414077324 |
| Fax |
|
| Email |
SUNCHA87@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tanya |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Departmet Of Anaesthesiology SMS Medical College And Hospital Jaipur Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9996218982 |
| Fax |
|
| Email |
tanyadahiya7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sunil Chauhan |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical College Jaipur |
| Address |
Department Of Anaesthesiology SMS Medical College And Hospital Jaipur Rajasthan.
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414077324 |
| Fax |
|
| Email |
SUNCHA87@yahooo.co.in |
|
|
Source of Monetary or Material Support
|
| Department Of Anaesthesiology SMS Medical College And Hospital Jaipur Rajasthan 302004 India |
|
|
Primary Sponsor
|
| Name |
SMS Medical College Jaipur |
| Address |
Department Of Anaesthesiology SMS Medical College And Hospital Jaipur Rajasthan 302004 India |
| 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 Sunil Chauhan |
SMS Medical College And Hospital |
Department Of Anaesthesiology SMS Medical College And Hospital Jaipur Rajasthan 302004
Jaipur
RAJASTHAN |
9414077324
SUNCHA87@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office Of Ethics Committee SMS Medical College And Hospitals |
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 |
| Comparator Agent |
Injection Esmolol |
Patient will receive intravenous injection esmolol 0.5 mg/kg diluted to 10ml with 0.9% saline 5 minutes before intubation over 60 seconds. |
| Comparator Agent |
Injection Labetalol |
Patient will receive intravenous inj labetalol 0.25 mg/kg diluted to 10ml with 0.9% saline 5 minutes before intubation over 60 seconds . |
| Intervention |
Injection Lignocaine |
Patient will receive intravenous inj lignocaine 1mg/kg diluted to 10ml with 0.9% saline 5 minutes before intubation over 60 seconds. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient who will give written informed consent.
2. Scheduled for urgent or elective procedures requiring endotracheal anaesthesia.
3. Classified as American Society of Anaesthesiologists (ASA) physiccal status I to II.
4. Patients age between 18 and 60 years
|
|
| ExclusionCriteria |
| Details |
1.Any contraindication or history of hypersensitivity to study drugs.
2. Presence of atrioventricular block of any degree.
3. History of cardiac arrhythmias or heart failure.
4. presence of kidney disease.
5. Body mass index(BMI)more than 25kgm2
6.Mallampatti grade 3 and 4
7. Patient should not be a part of any other study. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the effect of intravenous lignocaine verus labetalol versus esmolol on haemodynamic parameters (HR,SBP,DBP,MAP) to laryngoscopy and endotracheal intubation. |
At 0,1,5 and 10 minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess and compare proportion of patients developing any side effects.(Hypotension,Bradycardia,others) |
At 0,1,5 and 10 minutes after intubation
|
|
|
Target Sample Size
|
Total Sample Size="153"
Sample Size from India="153"
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)
|
01/01/2026 |
| 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="4"
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
|
This randomized controlled study is aimed to study the effects of intravenous lignocaine (1mg per kg) versus intravenous labetalol (0.25mg per kg) versus intravenous esmolol (0.5mg per kg) for attenuating the haemodynamic response to laryngoscopy and endotracheal intubation in patients undergoing elective surgeries under general anaesthesia. Patients are randomly assigned to receive either iv lignocaine ,iv labetalol or iv esmolol during the perioperative period. Haemodynamic parameters and side effects assesed at different intervals post intubation . |