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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.
 
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