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CTRI Number  CTRI/2024/11/076662 [Registered on: 12/11/2024] Trial Registered Prospectively
Last Modified On: 05/06/2025
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Surgical/Anesthesia 
Study Design  Single Arm Study 
Public Title of Study   Clinical Study to observe the safety of Remithem® in Indian patients 
Scientific Title of Study   A Prospective, Multi-centre, Open Label, Single-Arm, Non-interventional Observational Focused Pharmacovigilance Study to assess the safety of Remithem® in Indian patients. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
TML-REM-02-2023, Version 1.0, 27 Feb 2024  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Balaji More 
Designation  Vice President - Medical 
Affiliation  Themis Medicare Limited 
Address  11/12 Udyog Nagar,Goregaon (West)

Mumbai
MAHARASHTRA
400104
India 
Phone  8452959225  
Fax    
Email  balaji.more@themismedicare.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Balaji More 
Designation  Vice President - Medical 
Affiliation  Themis Medicare Limited 
Address  11/12 Udyog Nagar,Goregaon (West)


MAHARASHTRA
400104
India 
Phone  8452959225  
Fax    
Email  balaji.more@themismedicare.com  
 
Details of Contact Person
Public Query  
Name  Dr Balaji More 
Designation  Vice President - Medical 
Affiliation  Themis Medicare Limited 
Address  11/12 Udyog Nagar,Goregaon (West)


MAHARASHTRA
400104
India 
Phone  8452959225  
Fax    
Email  balaji.more@themismedicare.com  
 
Source of Monetary or Material Support  
Themis Medicare Limited 
 
Primary Sponsor  
Name  Themis Medicare Limited 
Address  11/12 Udyog Nagar, Goregaon (West),Mumbai-400104, Maharashtra, India. 
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 = 5  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Shekhar Reddy G  Apollo Hospitals  Department of Anesthesiology and Critical Care, Apollo Health City, Jubilee Hills, Hyderabad, 500096
Hyderabad
TELANGANA 		 9701002787

drshekhargreddy@yahoo.com 
Dr Anil Kumar Verma  Ganesh Shankar Vidyarthi Memorial Medical College  Department of Anesthesia and Trauma Care, 2nd Floor, Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH 		 9336107410

anil_1602197@rediffmail.co.in 
Dr Swati  Indira Gandhi Institute Of Medical Sciences  Department of Anesthesiology, OT Complex, 1st Floor, Ward Block, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Patna, Bihar-800014
Patna
BIHAR 		 9113463130

deepakswat@yahoo.com 
Dr Deepika Sathe  MGM Institute of Health Sciences  Department of Anesthesiology, MGM Educational Campus, Sector 1, Kamothe, Navi Mumbai-410209, Maharashtra State (India).
Raigarh
MAHARASHTRA 		 9819869990

sareendeepika31@gmail.com 
Dr Aruna Parameswari  Sri Ramachandra Medical College  Block 2, room no 3, Department of Anesthesia, Trunk Rd, Sri Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116
Chennai
TAMIL NADU 		 9840529863

hod.anaesthesiology@sriramachandra.edu.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee for Research on Human Subjects MGM Institute of Health Sciences, Navi Mumbai  Approved 
ETHICS COMMITTEE GSVM MEDICAL COLLEGE KANPUR  No Objection Certificate 
INSTITUTIONAL ETHICS COMMITTEE SRIHER, Sri Ramachandra Hospital, Chennai  Approved 
Institutional Ethics Committee, IGIMS ,Sheikhpura, Patna  Approved 
Institutional Ethics Committee, Sancheti Inst for Orthopedics and Rehabilitation, 16, Shivajinagar Sancheti Research Centre Pune, Pune Maharashtra - 411005 India.  Approved 
Institutional Ethics Committee-Clinical Studies APOLLO HOSPITALS ENTERPRISE LIMITED Research And Innovations, Hyderabad  Approved 
 
Regulatory Clearance Status from DCGI  
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  Not applicable   Not Applicable  
Intervention  Remifentanil Hydrochloride 1mg/2mg for Injection  Remifentanil Hydrochloride 1mg/2mg for Injection(Remithem®) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1.Male or female patients who will be administered Remithem® according to the recommendations provided in the product leaflet (Prescribing Information) and local recommendations.
2.Subject scheduled for a therapeutic and diagnostic surgical procedure requiring general anesthesia with Remifentanil as per Prescribing Information for the following indications
•As an analgesic agent for use during the induction and maintenance of general anesthesia for inpatient and outpatient procedures.
•For continuation as an analgesic into the immediate postoperative period in adult patients under the direct supervision of an anesthesia practitioner in a postoperative anesthesia care unit or intensive care setting.
•As an analgesic component of monitored anesthesia care in adult patients.
3.Subjects who provide written informed consent/Assent to abide by the study requirements.
 
 
ExclusionCriteria 
Details  1.Subjects having the absolute contraindication of the use of Remifentanil include previous anaphylaxis/allergy to Remifentanil or fentanyl analogues or any other component of Remifentanil. Remifentanil is contraindicated for use as the sole agent for induction of anaesthesia.
2.Subjects on regular oral benzodiazepine drugs.
3.Subjects suffering from known organic neurological disorders, psychiatric illnesses with or without treatment and having an ongoing history of alcohol and drug abuse (since past 1 month).
4.Subjects with severe cardiac, hepatic, gastrointestinal, renal, pulmonary and skin diseases.
5.Subjects treated with ACE inhibitors and Angiotensin II receptor blockers (ARBs) within 24 hours before the procedure. (Subject can be switched to Calcium channel blockers or Beta blockers if required)
6.Subjects receiving Gabapentin and Pregabalin.
7.Pregnant and lactating females.
8.Subjects simultaneously participating in another clinical study.
 
 
Method of Generating Random Sequence   Adaptive randomization, such as minimization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
subjects with any treatment emergent adverse event (TEAEs) during the study period that is from baseline to End of the study  Screening and Baseline(Day 1), End of the Study(Day 2) 
 
Secondary Outcome  
Outcome  TimePoints 
1. Subjects with any serious adverse event till End of Study (EOS)
2. Use of rescue analgesia during Surgery
3. Use of vasopressors during surgery 		 Baseline(Day 1) to End of the Study(Day 2) 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "200"
Final Enrollment numbers achieved (India)="200" 
Phase of Trial   Post Marketing Surveillance 
Date of First Enrollment (India)   18/11/2024 
Date of Study Completion (India) 04/09/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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   As this is a Non-interventional PMS study, all treatment and monitoring of the patients will be done at the discretion of the treating physician (investigator) as part of routine practice. Patients who agree to give informed consent (for data sharing)/assent will be enrolled. The dosage regimen will be decided by their anesthetist as recommended in the Package Insert for Remithem® (Remifentanil). 
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