| CTRI Number |
CTRI/2025/12/099712 [Registered on: 23/12/2025] Trial Registered Prospectively |
| Last Modified On: |
17/12/2025 |
| 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 the Effect of IV Labetalol and IV Lignocaine in Reducing the Rise in Blood Pressure and Heart Rate During Laryngoscopy and Intubation in Patients Undergoing Surgery at SMS Medical College Jaipur |
|
Scientific Title of Study
|
A Randomised Study to compare intravenous Labetalol versus Lignocaine for Attenuation of Hemodynamic response to Laryngoscopy and Endotracheal intubation in ,SMS 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 and Hospital Jaipur |
| Address |
Department of Anaesthesiology SMS Medical college and Hospital Jaipur Rajasthan 302004 India
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414077324 |
| Fax |
|
| Email |
Suncha87@yahoo.co.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Chauhan |
| Designation |
Senior Professor |
| Affiliation |
SMS Medical college and Hospital Jaipur |
| Address |
Department of Anaesthesiology SMS Medical college and Hospital Jaipur Rajasthan 302004 India
RAJASTHAN
302004
India |
| Phone |
9414077324 |
| Fax |
|
| Email |
Suncha87@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Rani |
| Designation |
Junior Resident |
| Affiliation |
SMS Medical college and Hospital Jaipur |
| Address |
Department of Anaesthesiology SMS Medical college and Hospital Jaipur Rajasthan 302004 India
Jaipur
RAJASTHAN
302004
India |
| Phone |
7206999837 |
| Fax |
|
| Email |
amritatamak@gmail.com |
|
|
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, Jaipur |
General Surgery OT Complex , Department of Anaesthesiology
Jaipur
RAJASTHAN |
9414077324
Suncha87@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Office of the Ethics Committee, SMS Medical College and Attached Hospitals,Jaipur |
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 |
Attenuating the pressor response to laryngoscopy and endotracheal intubation under general anaesthesia |
Attenuating the pressor response to laryngoscopy and endotracheal intubation by use of intravenous injection of labetalol 0.75mg per kg and lignocaine 1.5mg per kg upto 10 minutes after intubation under general anaesthesia |
| Comparator Agent |
Effect of injection Labetalol 0.75 mg per kg intravenous dose. |
Effectiveness of injection labetalol 0.75 mg per kg intravenous dose for attenuating the pressor response to laryngoscopy and endotracheal intubation under general anaesthesia. |
| Comparator Agent |
Effect of injection Lignocaine 1.5 mg per kg intravenous dose. |
Effectiveness of injection lignocaine 1.5 mg per kg intravenous dose for attenuating the pressor response to laryngoscopy and endotracheal intubation under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient undergoing elective surgical procedures under general anaesthesia and endotracheal intubation.
2.Patients willing to give written and Informed consent.
3. Adult patients aged 18 to 60 years.
4.Both sex.
5.Patients belonging to ASA (American society of Anesthesiologist ) grade I. |
|
| ExclusionCriteria |
| Details |
1. History of chest pain/syncope/palpitations.
2. Any contraindications or history of hypersensitivity to study drugs.
3. Any respiratory problems.
4. Hepatic and renal issues.
5. Any abnormalities in the ECG.
6. Anticipated difficult intubation.
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
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in changes in heart rate from baseline to different time intervals in two groups. |
0,1,3,5,10 minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in changes in hemodynamic responses (SBP,DBP,MAP)from baseline to different time intervals in two groups. |
0,1,3,5,10 minutes after intubation. |
|
|
Target Sample Size
|
Total Sample Size="66"
Sample Size from India="66"
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)
|
05/01/2026 |
| 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="2"
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
|
In this study we will compare effectiveness of intravenous labetalol(0.75mg/kg) and lignocaine (1.5mg/kg) for attenuating the hemodynamic responses to laryngoscopy and endotracheal intubation in adult patients undergoing surgeries under general anaesthesia. |