| CTRI Number |
CTRI/2026/03/105899 [Registered on: 11/03/2026] Trial Registered Prospectively |
| Last Modified On: |
11/03/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparative Assessment of Esmolol and Labetalol in Controlling Hemodynamic Responses During Tracheal Extubation Following Abdominal Surgery |
|
Scientific Title of Study
|
Attenuation of Hemodynamic response to tracheal Extubation; A comparative randomised study between esmolol and labetalol in abdominal surgeries. |
| 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 DHARITRI TAMULY |
| Designation |
Post Graduate Student |
| Affiliation |
Department of Anaesthesia, Gauhati medical college and hospital |
| Address |
Department of Anaesthesia and Critical Care, Gauhati Medical
college and Hospital,Bhangagarh, Guwahati-781032
Kamrup
ASSAM
781032
India |
| Phone |
9706056044 |
| Fax |
|
| Email |
tamuly.dharitri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Head of Department, Professor |
| Affiliation |
Department of Anaesthesia, Gauhati medical college and hospital |
| Address |
Department of Anaesthesia and Critical Care, Gauhati Medical
college and Hospital, Bhangagarh, Guwahati-781032
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Rajib Hazarika |
| Designation |
Head of Department, Professor |
| Affiliation |
Department of Anaesthesia, Gauhati medical college and hospital |
| Address |
Department of Anaesthesia and Critical Care, Gauhati Medical
college and Hospital, Bhangagarh, Guwahati-781032
Kamrup
ASSAM
781032
India |
| Phone |
9864063140 |
| Fax |
|
| Email |
rajibhazarika8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gauhati Medical College and Hospital, Bhangagarh, Guwahati-781032 |
|
|
Primary Sponsor
|
| Name |
DR. DHARITRI TAMULY |
| Address |
Post graduate student, Department of Anaesthesia and Critical
care, Gauhati medical college and Hospital, Guwahati-781032 |
| Type of Sponsor |
Other [Self] |
|
|
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 Rajib Hazarika |
Gauhati Medical College and Hospital |
All Operation
Theatres where General Anaesthesia will be given.
Kamrup
ASSAM |
9864063140
rajibhazarika8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of Gauhati 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 |
| Intervention |
ESMOLOL |
the patients will receive 1.5 mg/kg esmolol intravenously 2 min before extubation |
| Comparator Agent |
LABETALOL |
the patients will receive 0.25 mg/kg labetalol intravenously 2 min before extubation |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
patients with ASA grade 1 and 2
Patients with informed consent for the study
Patients with planned abdominal surgery less than 120 minutes |
|
| ExclusionCriteria |
| Details |
Patient refusal for consent
Patients with emergency surgeries
Patients with ASA 3 or more
Patients with bronchial asthma, Type 2 DM, Hypothyroidsm, Bleeding Diastasis, Hypertension
Patients with Atrioventricular block
Body mass index more than 35kg/ meter square
Patients with Heart Rate less than 60/min and Blood Pressure less than 90/60 mmHg |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
measurement of Heart Rate, Systolic Blood Pressure , Diastolic Blood Pressure , Mean Arterial Pressure starting from time when the surgery ends till 5 minutes post tracheal extubation.
|
basal, at the time of reversal, at the time of giving reversal, at the time of giving drug, 1 min after giving drug, at extubation , 1 min post extubation, 3 min post extubation, 5 min post extubation
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| measurement of Heart Rate, Systolic Blood Pressure , Diastolic Blood Pressure , Mean Arterial Pressure from 5 minutes to 30 minutes post tracheal extubation. |
15 minutes post extubation, 30 minutes post extubation |
| Adverse events |
1 hour post extubation |
|
|
Target Sample Size
|
Total Sample Size="92"
Sample Size from India="92"
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)
|
25/03/2026 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 is a prospective, double-blind , randomised control study to be conducted in various Operation Theatres under the Department of Anaesthesiology and Critical Care, Gauhati Medical college and hospital, Guwahati. The study will be carried out on patients of age 18 to 50 years old of both sexes posted for elective surgeries. The aim of this study is to compare the efficacy of esmolol and labetalol in attenuating hemodynamic response ( HR, SBP, DBP, MAP ) to tracheal extubation of patients undergoing General Anaesthesia. The Secondary objective of this study is to compare the hemodynamic change in Heart rate , Systolic Blood Pressure, Diastolic Blood pressure, Mean Arterial Pressure till 30 min post extubation and adverse effects if any , post administration of drug. |