| CTRI Number |
CTRI/2025/12/098924 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| 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 to compare which dose of labetalol is better to reduces heart stress response during removal of breathing tube from respiratory tract after gallbladder surgery under general anaesthesia. |
|
Scientific Title of Study
|
A Randomized Study to Compare the Effect of Two Different Doses of Intravenous Labetalol for Attenuation of Hemodynamic Response During Endotracheal Extubation in Laparoscopy Cholecystectomy Under General Anaesthesia at 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
Jaipur
RAJASTHAN
302004
India |
| Phone |
9414077324 |
| Fax |
|
| Email |
Suncha87@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sonal Katara |
| 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 |
7073275184 |
| Fax |
|
| Email |
katarasonal996@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 SMS Medical College and Hospital Jaipur Rajasthan 302004 India
Jaipur
RAJASTHAN |
09414077324
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 hemodynamic
response during endotracheal extubation under general anaesthesia |
Attenuating the hemodynamics
response during endotracheal extubation by use of two different doses (0.2 mg/kg and 0.1 mg/kg) of intravenous labetalol upto 10 minutes after extubation under general anaesthesia. |
| Comparator Agent |
Effect of injection labetalol 0.1 mg per kg intravenous dose. |
Effectiveness of injection labetalol 0.1 mg per kg intravenous dose for attenuating the hemodynamic response during endotracheal extubation under general anaesthesia. |
| Comparator Agent |
Effect of injection labetalol 0.2 mg per kg intravenous dose. |
Effectiveness of injection labetalol 0.2 mg per kg intravenous dose for attenuating the hemodynamic response during endotracheal extubation under general anaesthesia. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients scheduled for elective laparoscopic cholecystectomy surgeries under general anaesthesia.
2. Patients belonging to ASA (American society of anaesthesiologist) physical status grade I and II.
3. Patients willing to give written and informed consent.
4.Patients of either sex.
5.Age group between 18 years to 60 years.
|
|
| ExclusionCriteria |
| Details |
1.Pregnant women.
2.Patients with history of known allergy to study drugs.
3.Any contraindication of study drugs.
4.History of drug and alcohol abuse.
5.Patients 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 determine the difference in changes in SBP from baseline to different time intervals in two groups. |
Before extubation, 1,3,5 and 10 min after extubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the difference in changes in hemodynamic reponses (DBP,MAP,HR) from baseline to different time intervals in two groups. |
Before extubation, 1,3,5 and 10 min after extubation. |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
24/12/2025 |
| 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 randomized study we will compare of two different doses (0.2 mg per kg and 0.1 mg/kg) of intravenous labetalol , which one is more effective for attenuation of hemodynamic response during endotracheal extubation in patients undergoing elective laparoscopy cholecystectomy under general anaesthesia . |