| CTRI Number |
CTRI/2026/02/102760 [Registered on: 02/02/2026] Trial Registered Prospectively |
| Last Modified On: |
30/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Comparison of Different Doses of Remifentanil on Heart Rate and Blood Pressure Changes During Anesthesia |
|
Scientific Title of Study
|
Effect of Different Doses of Remifentanil on Hemodynamic Response after Endotracheal Intubation in a Tertiary Care Hospital: An Open Label 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 |
Harsh Gupta |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesia and critical care, All India Institute of Medical Sciences, Deoghar
Deoghar JHARKHAND 814152 India |
| Phone |
7055226915 |
| Fax |
|
| Email |
guptaharsh7122000@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Ripon Choudhary |
| Designation |
Associate professor |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesia and critical care, All India Institute of Medical Sciences, Deoghar
Deoghar JHARKHAND 814152 India |
| Phone |
9914789458 |
| Fax |
|
| Email |
ripon85@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Harsh Gupta |
| Designation |
Junior resident |
| Affiliation |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesia and critical care, All India Institute of Medical Sciences, Deoghar
Deoghar JHARKHAND 814152 India |
| Phone |
7055226915 |
| Fax |
|
| Email |
guptaharsh7122000@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical
Sciences, Deoghar, Devipur, Deoghar, Jharkhand, India PIN -
814152 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences, Deoghar |
| Address |
Department of Anaesthesia and Critical care, All India Institute of Medical
Sciences, Deoghar, Devipur, Deoghar, Jharkhand, India PIN -
814152 |
| 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 Harsh Gupta |
All India Institute of Medical Sciences, Deoghar |
Operation theatre
complex, All India
Institute of Medical
Sciences, Deoghar,
Devipur. Deoghar JHARKHAND |
7055226915
guptaharsh7122000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| 18th IEC subcommittee |
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 |
Inj Nalbuphine |
0.1mg/kg iv |
| Intervention |
Inj Remifentanil + Inj Nalbuphine |
Remifentanil 1.0mcg/kg + Nalbuphine 0.1mg/kg |
| Intervention |
Inj Remifentanil + Inj Nalbuphine |
Remifentanil 1.5mcg/kg + Nalbuphine 0.1mg/kg |
| Intervention |
Inj Remifentanil + Inj Nalbuphine |
Remifentanil 2.0mcg/kg + Nalbuphine 0.1mg/kg |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Elective surgeries under general anaesthesia
2. Duration of surgery 45 minutes to 2 hours
3. ASA physical status 1 and 2 |
|
| ExclusionCriteria |
| Details |
1. Uncontrolled hypertension
2. Severe hypotension
3. Emergency Surgery
4. Negative consent
5. Difficult airway |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the changes in heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), and mean arterial pressure (MAP) following laryngoscopy and endotracheal intubation among different doses of remifentanil. |
1. Baseline (after preoxygenation)
2. 1 min after endotracheal intubation
3. 5 min after endotracheal intubation
4. 10 min after endotracheal intubation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the incidence of side effects associated with different doses of remifentanil. |
0-2 hours, 2-6 hours, 6-24 hours |
|
|
Target Sample Size
|
Total Sample Size="80" Sample Size from India="80"
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)
|
14/02/2026 |
| 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="6" 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
|
Laryngoscopy and endotracheal intubation are associated with significant sympathetic stimulation resulting in transient increases in heart rate and blood pressure, which may be harmful in susceptible patients. Various pharmacological agents are used to attenuate this hemodynamic response. Remifentanil, an ultra-short acting opioid, has been shown to be effective for this purpose; however, the optimal dose that provides adequate attenuation with minimal adverse effects remains uncertain.
This prospective, open-label study will be conducted at a tertiary care hospital to evaluate and compare the effects of different doses of intravenous remifentanil on the hemodynamic response to endotracheal intubation in adult patients undergoing elective surgery under general anesthesia. Participants will be allocated into four groups: a control group receiving standard induction without remifentanil, and three intervention groups receiving remifentanil at doses of 1 µg/kg, 1.5 µg/kg, and 2 µg/kg, respectively, during induction of anesthesia. Hemodynamic parameters including heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure will be recorded at baseline, during laryngoscopy, and at predetermined intervals following endotracheal intubation. The study aims to identify the dose of remifentanil that most effectively attenuates the hemodynamic response to intubation with minimal adverse effects. |