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CTRI Number  CTRI/2021/01/030800 [Registered on: 28/01/2021] Trial Registered Prospectively
Last Modified On: 20/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   To compare the safety and efficacy of Remifentanil with Fentanyl for pain relief during induction and maintenance of general anesthesia  
Scientific Title of Study   A Prospective, multicenter, observer blind, randomized, 3 arm, parallel group, Phase III comparative study to evaluate the safety and efficacy of two formulations of remifentanil and fentanyl for analgesia during the induction and maintenance of general anesthesia 
Trial Acronym  REM-01 
Secondary IDs if Any  
Secondary ID  Identifier 
TML/REMI-01 v 3.0 Dated 30 OCT 2020  Protocol Number 
CT/ND/84/2017  DCGI 
F.No.12-10/17-DC  DCGI 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Dr Indrani Hemanthkumar  
Designation  Principal Investigator 
Affiliation   
Address  1003A, Lady Ratan Towers, D S Marg, Worli, Mumbai

Mumbai
MAHARASHTRA
400018
India 
Phone  9819967609  
Fax    
Email  indiranih@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Ashok Kumar Swain 
Designation  General Manager 
Affiliation  Themis Medicare Limited 
Address  Medical Affairs Themis Medicare Limited 11/12 Udyog Nagar Goregaon (West) Mumbai

Mumbai (Suburban)
MAHARASHTRA
400104
India 
Phone  09160255553  
Fax    
Email  ashok.swain@themismedicare.com  
 
Details of Contact Person
Public Query  
Name  Sangameshwar Iyer 
Designation  Company Secretary 
Affiliation  Themis Medicare Limited 
Address  Medical Affairs Themis Medicare Limited 11/12 Udyog Nagar Goregaon (West) Mumbai

Mumbai (Suburban)
MAHARASHTRA
400104
India 
Phone  9769692460  
Fax    
Email  sangameshwar.iyer@themismedicare.com  
 
Source of Monetary or Material Support  
Themis Medicare Limited, 11/12 Udyog Nagar, Goregaon (West), Mumbai - 400104 
 
Primary Sponsor  
Name  Themis Medicare Limited  
Address  11/12 Udyog Nagar, Goregaon (West), Mumbai - 400104  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 14  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Basantha Kumar Rayani  Basavatarakam Indo American Cancer Hospital & Research Institute  Block No. 2, 2nd floor, Basavatharakam Indo-american Cancer Hospital, Road No. 10, IAS Officers Quaters, Nandi Nagar, Banjara Hills, Hyderabad, Telangana 500034
Hyderabad
TELANGANA 		 9963501766

basanthrayani@gmail.com 
Dr Sandeep Patil  CIMRTs Inamdar Multispeaciality Hospital  S.No. 15, Fatima Nagar, Wanvadi
Pune
MAHARASHTRA 		 02066812475

sandeeppatilindia@gmail.com 
Dr Balasubramanyam P K  Columbia Asia Hospital  Columbia Asia Hospital, No. 85-86, Bangalore Mysore Ring Road Junction, Bannimantapa A Layout, Siddiqui Nagar, Mysuru (India) - 570015 India
Mysore
KARNATAKA 		 9886716014

pkbali007@gmail.com 
Dr Swati  Indira Gandhi Institute of Medical Sciences  Allahabad bank, Bailey Rd, Sheikhpura, Patna, Bihar 800014
Patna
BIHAR 		 8544413241

deepakswat@yahoo.com 
Dr Manjaree Mishra  Institute of Medical Sciences BHU  Aurobindo Colony, Banaras Hindu University Campus, Varanasi, Uttar Pradesh 221005
Varanasi
UTTAR PRADESH 		 9452030526

drmanjareemd@gmail.com 
Dr Gurudath CL  JSS Medical College  Bangalore - Mysore Rd, opposite J.S.S.Pharmacy College, Bannimantap A Layout, Bannimantap, Mysuru, Karnataka 570015
Mysore
KARNATAKA 		 9845312311

clgurudath@jssuni.edu.in 
Dr Narendra Babu  KIMS Hospital and Research Centre  OPD No. 12, Ground Floor, B Block, KIMS Hospital, Krishna Rajendra Rd, Vishweshwarapura, Bengaluru, Karnataka 560004
Bangalore
KARNATAKA 		 9900214064

narendrababuchanappa@gmail.com 
Dr Shrikanta Oak  King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College  Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012
Mumbai
MAHARASHTRA 		 9324134023

shrikanta_oak@yahoo.com 
Dr Sanhita Jiten Kulkarni  MGM Medical College & Hospital  Gate No. 2 , MGM Campus, N-6, Cidco, Aurangabad, Maharashtra 431003
Aurangabad
MAHARASHTRA 		 9881300645

drsanhitakulkarni@gmail.com 
Dr Padmaja Durga  Nizams Institute of Medical Sciences  Punjagutta Rd, Punjagutta Market, Punjagutta, Hyderabad, Telangana 500082
Hyderabad
TELANGANA 		 9440387299

padmajanims@yahoo.com 
Dr Pallavi Butyani  NOBLE HOSPITAL HADAPSAR  Noble Hospital Pvt Ltd, 153 A Magarpatta road, Clinical research Department, Hadapsar.
Pune
MAHARASHTRA 		 02043285000

pallavibutyani@gmail.com 
Dr Giridhar Janampet Bekkam  Panimalar Medical College Hospital & Research Institute  Varadharajapuram, Poonamallee, Chennai, Tamil Nadu 600123
Chennai
TAMIL NADU 		 9949032277

giridharjb@gmail.com 
Dr Amrutha Bindu  Sapthagiri Hospital  Hesarghatta Main Rd, Navy Layout, Chikkasandra, Chikkabanavara, Bengaluru, Karnataka 560090
Bangalore
KARNATAKA 		 7829433991

amruthanagella@gmail.com 
Dr Amitabh Dutt  Sir Ganga Ram Hospital  Sir Ganga Ram Hospital, Sarhadi Gandhi Marg, near Bal Bharati Public School, Old Rajinder Nagar, Rajinder Nagar, New Delhi, Delhi 110060
New Delhi
DELHI 		 01142252513

duttaamitabh@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 14  
Name of Committee  Approval Status 
Ethics Committee Inamdar Multispeaciality Hospital  Approved 
IEC, King Edward Memorial Hospital and Seth Gordhandas Sunderdas Medical College  Approved 
Institutional Ethics Committee IMS BHU  Approved 
Institutional Ethics Committee, basvatarakam Indo-American Cancer Hospital & Research Institute  Approved 
Institutional ethics committee, Columbia Asia  Approved 
Institutional Ethics Committee, Indira Gandhi Institute of Medical Sciences Sheikpura, Patna, 800014  Approved 
institutional ethics committee, JSS medical college  Approved 
KIMS Institutional Ethics Committee  Approved 
MGM INSTITUTIONAL ETHICS COMMITTEE NAVI MUMBAI  Approved 
NIMS Institutional Ethics Committee, Nizam Institute of Medical Sciences, Hyderabad   Approved 
Noble Hospital institutional Ethics Committee  Approved 
Panimalar Medical College Hospital & Research Institute Institutional Human Ethics Committee  Approved 
Sapthagiri Institute of Medical Science and Research Centre, Institutional Ethics Committee  Approved 
Sir Ganga Ram Hospital Ethics Committee, Sir Ganga Ram Hospital  Approved 
 
Regulatory Clearance Status from DCGI
Modification(s)  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Fentanyl  100mcg/2ml (2 ampoules) or 200mcg dilute in 50ml (4mcg/ml) 
Intervention  Remifentanil Hydrochloride   Remifentanil, 1mg lyophilized powder will be diluted in 50ml normal saline to attain a concentration of 20mcg/ml 
Comparator Agent  Ultiva (Remifenatnyl Hydrochloride)  Remifentanyl 1mg lyophilized powder will be diluted in 50ml normal saline to attain a concentration of 20mcg/ml. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Subjects of either sex in the age group
between 18 to 65 years(inclusive) at the time
of signing ICF.

2. Subject scheduled for elective therapeutic and
diagnostic surgical procedure with estimated
duration of at least 30 minutes and up to
approximately 120 minutes with an American
society of anesthesiologists (ASA) physical
status scale ranging from ASA1 or ASA2 and
required hospitalization for at least 24
hours.

3. Subjects who provide a written informed
consent to abide by the study requirements. 
 
ExclusionCriteria 
Details  1. Subjects known or suspected to have an allergy to narcotics, muscle relaxants or other medication used during general anaesthesia.
2. Subjects with BMI > 35.
3. Subjects on regular oral benzodiazepines drugs.
4. Subjects suffering from known organic neurological disorders, psychiatric illnesses with or without treatment and history of drug abuse and history of alcohol abuse.
5. Subjects with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
6. Subjects treated with ACE inhibitor and Angiotensin II receptor blockers (ARBs) within 24 hours before procedure. (Subject can be switched to Calcium channel blockers or Beta blockers if required)
7. Subjects receiving Gabapentin and pregabalin.
8. Subjects with known hypersensitivity to any of the ingredients of the test / comparator formulation.
9. Subjects whose screening lab values are exceeding the upper limit of normal range significantly
10. Subjects who have positive serology tests.
11. Pregnant and lactating females.
12. Subjects simultaneously participating in another clinical study.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Number of subjects who experienced
a. Bradycardia
b. Tachycardia
c. Hypertension
d. Hypotension
e. Respiratory depression
f. Agitation


To evaluate the adequacy of intra-operative analgesia as measured by hemodynamic response to noxious stimuli 		 • Laryngeal Intubation
• Skin incision
• Skin closure
• Extubation

Time points for the assessment will be on Day-1 between 30 to 120 mins. 
 
Secondary Outcome  
Outcome  TimePoints 
1. Number of Subjects who experienced muscle rigidity
2. No. of additional doses of propofol or any study drugs required during the entire surgical procedure period.
3. No. of subjects who required vasopressors drugs like mephenteramine.
4. No. of subjects who required anticholinergic drugs like atropine and Glycopyrrolate
5. Number of subjects who required naloxone administration.

 		 All haematological, investigations will be repeated 24 hours post surgery as applicable.

Time point: On Day 2 (upto 24 hours post surgery as applicable) 
 
Target Sample Size   Total Sample Size="321"
Sample Size from India="321" 
Final Enrollment numbers achieved (Total)= "321"
Final Enrollment numbers achieved (India)="321" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 24/11/2021 
Date of Study Completion (India) 31/03/2022 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="7"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Study Objective: To evaluate the safety and efficacy of two formulations of remifentanil and fentanyl for analgesia during the induction and maintenance of general anesthesia.
Study Design: Prospective, multicenter, observer blind, randomized, 3 arm, parallel group, comparative study to evaluate the safety and efficacy of two formulations of remifentanil and fentanyl for analgesia during the induction and maintenance of general anesthesia.
Subject will be divided into three groups
All subjects will receive Propofol and Sevoflurane as anesthetic agent.
Target Population: 321
Efficacy Parameters: Primary endpoint
To evaluate the adequacy of intra-operative analgesia as measured by hemodynamic response to noxious stimuli during
• Laryngeal Intubation
• Skin incision
• Skin closure
• Extubation
Secondary endpoint
1. Number of Subjects who experienced muscle rigidity
2. No. of additional doses of propofol or any study drugs required during the entire surgical procedure period.
3. No. of subjects who required vasopressors drugs like mephenteramine.
4. No. of subjects who required anticholinergic drugs like atropine and Glycopyrrolate
5. Number of subjects who required naloxone administration.
Safety parameters:
1. Biochemical Examinations- Hematological; CBC, ESR, SGOT, SGPT, serum proteins, A/G ratio, Alkaline phosphatase, serum bilirubin, random blood Glucose, BUN, S. Electrolytes and serum creatinine.
2. ECG
3. ADR Recording
4. Vitals- BP, Temperature, Heart rate (Pulse)
Assessment Schedule:-
The study will involve Screening (Day 0), Randomization, Day of surgery and IP administration (Day 1) and EOS (Day 2). Total study duration is 48 hours approximately (24 hours prior to surgery and 24 hours after the surgery).

 
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