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CTRI Number  CTRI/2024/05/067293 [Registered on: 14/05/2024] Trial Registered Prospectively
Last Modified On: 10/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparative study between intravenous remifentanil and intravenous fentanyl in controlling blood pressure, Heart rate in patients undergoing General Anaesthesia. 
Scientific Title of Study   A Comparative study between Remifentanil and Fentanyl in attenuation of hemodynamic response to Laryngoscopy and Tracheal Intubation in patients undergoing General Anesthesia requiring Endotracheal Intubation– A double blinded randomized controlled trial. 
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 D Merlin Lydia 
Designation  Junior Resident 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology Pondicherry Institute of Medical Sciences, Kalapet, Pondicherry 605014 Pondicherry India

Pondicherry
PONDICHERRY
605014
India 
Phone  9962123571  
Fax    
Email  merlinlydia257@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Sivakumar S 
Designation  Professor 
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology Pondicherry Institute of Medical Sciences, Kalapet, Pondicherry 605014 Pondicherry PONDICHERRY India

Pondicherry
PONDICHERRY
605014
India 
Phone  9944060676  
Fax    
Email  siva85dr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr D Merlin Lydia 
Designation  Junior resident  
Affiliation  Pondicherry Institute of Medical Sciences 
Address  Department of Anaesthesiology Pondicherry Institute of Medical Sciences, Kalapet, Pondicherry 605014 Pondicherry PONDICHERRY 605014 India

Pondicherry
PONDICHERRY
605014
India 
Phone  9962123571  
Fax    
Email  merlinlydia257@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology, Pondicherry Institute of Medical Sciences, Kalapet, Pondicherry 605014 , Pondicherry , India 
 
Primary Sponsor  
Name  Pondicherry Institute of Medical Sciences 
Address  Pondicherry Institute of Medical Sciences,Ganapathichettikulam ,Kalapet,Puducherry-605014 
Type of Sponsor  Private 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 D Merlin Lydia  Pondicherry Institute of Medical Sciences Hospital  Room No 216 , Department of Anaesthesiology Ganapathichettikulam Kalapet, Puducherry 605014
Pondicherry
PONDICHERRY 		 9962123571

merlinlydia257@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
PIMS INSTITUTE ETHICS COMMITTEE  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  Injection Fentanyl   Injection Fentanyl 2mcg/kg IV diluted in 5ml saline given over one minute before starting of induction 
Intervention  Injection Remifentanil   Injection Remifentanil 2mcg/kg IV diluted in 5ml saline given over one minute , 2 minutes before intubation. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age 18 – 60 years of either sex.
American society of Anesthesiologist 1 and 2 patients. (ASA 1 – A normal healthy
patient, ASA 2 – A patient with mild systemic disease). 
 
ExclusionCriteria 
Details  Patients undergoing emergency surgeries.
2. Pregnant women
3. Patients with uncontrolled hypertension
4. Cardiovascular and cerebrovascular disease
5. Known allergy to study drug
6. Anticipated difficult intubation.
7. Patients on beta blockers 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
To compare the efficacy of bolus dose of remifentanil (2μg/kg) and bolus dose of fentanyl (2μg/kg) in attenuating heart rate response to laryngoscopy and intubation in patients undergoing General Anesthesia.  The hemodynamic parameters like heart rate , systolic blood pressure , diastolic blood pressure , mean arterial pressure will be measured and recorded at 0, 1 , 2 , 3, 4, 5 minutes and every 5 minutes for the next 30 minutes and every 15 minutes thereafter till the end of surgery  
 
Secondary Outcome  
Outcome  TimePoints 
To compare the incidence of complications (bradycardia, hypotension, hypertension) between both the groups  Patient’s hemodynamic parameters like Heart Rate, Systolic Blood Pressure, Diastolic Blood Pressure, Mean Arterial Pressure will be checked every minute for the initial 5minutes and every 5 minutes for next 30 minutes and every 15 minutes thereafter till the end of surgery. 
 
Target Sample Size   Total Sample Size="72"
Sample Size from India="72" 
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)   01/06/2024 
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="2"
Months="0"
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   The hemodynamic response to laryngoscopy and intubation is represented by an abrupt rise in the heart rate and arterial blood pressure within 30 seconds and returning to the baseline values steadily within 5-10 minutes . opioids with short half life has proven advantages over fentanyl for modulating circulatory responses to intubation . Remifentanil is s novel opioid drug with a distinct chemical structure . owing to its rapid onset and quick half-life , it would be the opioid of choice for attenuating the pressor response to a brief but unpleasant stimulus. 
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