| CTRI Number |
CTRI/2026/02/103601 [Registered on: 11/02/2026] Trial Registered Prospectively |
| Last Modified On: |
10/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison between two drugs for use in General Anaesthesia in Patients Undergoing Laparoscopic Cholecystectomy. |
|
Scientific Title of Study
|
Comparing Intravenous Nalbuphine Vs Clonidine for Attenuating Laryngoscopy related Blood Pressure Surge for Patients Undergoing Laparoscopic Cholecystectomy Under General Anaesthesia: A Double-blind Randomized controlled study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Samiran Maiti |
| Designation |
Post Graduate Trainee Anaesthesiology |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
College of Medicine and Sagore Dutta Hospital,Department of Anaesthesiology, Barrackpore Trunk Road, Kolkata, West Bengal, Pin 700058
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
9618137412 |
| Fax |
|
| Email |
samiran1802@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nairita Mayur |
| Designation |
Assistant Professor |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
College of Medicine and Sagore Dutta Hospital,Department of Anaesthesiology, Barrackpore Trunk Road, Kolkata, West Bengal, Pin 700058
North Twentyfour Parganas
WEST BENGAL
700058
India |
| Phone |
9474862764 |
| Fax |
|
| Email |
nairitalive@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nairita Mayur |
| Designation |
Assistant Professor |
| Affiliation |
College of Medicine and Sagore Dutta Hospital |
| Address |
College of Medicine and Sagore Dutta Hospital,Department of Anaesthesiology, Barrackpore Trunk Road, Kolkata, West Bengal, Pin 700058
WEST BENGAL
700058
India |
| Phone |
9474862764 |
| Fax |
|
| Email |
nairitalive@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology,College of Medicine and Sagore Dutta Hospital. |
|
|
Primary Sponsor
|
| Name |
College of Medicine and Sagore Dutta Hospital |
| Address |
College of Medicine and Sagore Dutta Hospital,Department of Anaesthesiology, Barrackpore Trunk Road, Kolkata, West Bengal, Pin 700058 |
| 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 Nairita Mayur |
College of Medicine and Sagore Dutta Hospital |
Department of Anaesthesiology, Barrackpore Trunk Road, Kolkata, West Bengal,Pin 700058
North Twentyfour Parganas
WEST BENGAL |
9474862764
nairitalive@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee College of Medicine and Sagore Dutta 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 |
| Comparator Agent |
Intravenous Clonidine as a premedication. |
To evaluate the efficacy of the drug when used as a premedication for general anaesthesia in attenuating the hemodynamic response (blood pressure and heart rate rise) associated with laryngoscopy and endotracheal intubation. |
| Intervention |
Intravenous Nalbuphine as a premedication. |
To evaluate the efficacy of the drug when used as a premedication for general anaesthesia in attenuating the hemodynamic response (blood pressure and heart rate rise) associated with laryngoscopy and endotracheal intubation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients undergoing elective laparoscopic cholecystectomy under general anaesthesia.
2. Patients who have given written informed consent to participate in the study.
3. Patients with ASA (American Society of Anaesthesiologist) grade I and II |
|
| ExclusionCriteria |
| Details |
1.Patienst with ASA grade III and IV
2.Patients refusal for participation in study
3.Patients with hepatic, renal or cardiopulmonary abnormality
4.Patients with uncontrolled hypertension and diabetes mellitus
5.Patients with psychiatric illness
6.Patients with hypersensitivity to any of the research drugs.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare systolic blood pressure, diastolic blood pressure and mean arterial pressure changes during laryngoscopy between the two drugs. |
Systolic blood pressure, diastolic blood pressure and mean arterial pressure will be recorded at baseline, after giving study drug, immediately after laryngoscopy and intubation, 1st, 3rd, 5th, 7th 10th, and 15th minutes after intubation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare heart rate changes during laryngoscopy between the two drugs. |
Heart rate will be recorded at baseline, after giving study drug, immediately after laryngoscopy and intubation, 1st, 3rd, 5th, 7th 10th, and 15th minutes after intubation. |
| To compare the side effects of the two adjuvants used(if any). |
Intraoperative and postoperative period. |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
01/03/2026 |
| 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="0"
Months="10"
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
|
Endotracheal intubation is an essential component of general anaesthesia. Laryngoscopy and tracheal intubation in general anaesthesia stimulate nociceptive afferent fibres which induce reflex sympatho adrenal responses.
Side effects of laryngoscopy and intubation are increase in blood pressure and heart rate. These hemodynamic changes cause cardiac arrhythmias, myocardial ischemia, and cerebral haemorrhage like complications.
To blunt this pressor response, various agents like opioids, beta blockers, vasodilators, calcium channel blockers, inhalation agents, lignocaine have been tried.
Our study objective is to compare Nalbuphine with conventionally used Clonidine to evaluate the efficacy of both drugs in attenuating laryngoscopy related blood pressure surge in patients undergoing laparoscopic cholecystectomy under general anaesthesia. |