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CTRI Number  CTRI/2025/11/096892 [Registered on: 04/11/2025] Trial Registered Prospectively
Last Modified On: 04/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Study Comparing The Effects Of Two Pain Medications Remifentanil And Fentanyl On Blood Pressure, Heart Rate And Recovery After Brain Surgery. 
Scientific Title of Study   Comparison Of Effects Of Remifentanil And Fentanyl On Hemodynamics And Recovery In Patients Undergoing Elective Craniotomy Under General Anaesthesia ,A Prospective Observational Single Center Double Blind Study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
IEC-II(IRB)/1855/AL/25/26  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DrShwetal Goraksha 
Designation  Consultant Anaesthesiologist 
Affiliation  Dept. of Neuroanaesthesia, P.D.Hinduja Hospital and Medical Research Centre,Mahim 
Address  Anaesthesia office ,Dept.of Anaesthesia ,OT complex 3rd floor IPD Of P.D.Hinduja Hospital and Medical Research Centre ,Swatantrya Veer Savarkar road, Mahim, Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  9819570713  
Fax    
Email  shwetalgoraksha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  DrShwetal Goraksha 
Designation  Consultant Anaesthesiologist 
Affiliation  Dept. of Neuroanaesthesia, P.D.Hinduja Hospital and Medical Research Centre,Mahim 
Address  Anaesthesia office ,Dept.of Anaesthesia ,OT complex 3rd floor IPD Of P.D.Hinduja Hospital and Medical Research Centre ,Swatantrya Veer Savarkar road, Mahim,Mumbai

Mumbai
MAHARASHTRA
400016
India 
Phone  9819570713  
Fax    
Email  shwetalgoraksha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Renukadevi Tulshidas Shilimkar  
Designation  DrNB NEUROANESTHESIA RESIDENT  
Affiliation  Dept. of Neuroanaesthesia, P.D.Hinduja Hospital and Medical Research Centre 
Address  Anaesthesia office ,Dept.of Anaesthesia ,OT complex 3rd floor IPD Of P.D.Hinduja Hospital and Medical Research Centre ,Swatantrya Veer Savarkar road, Mahim

Mumbai
MAHARASHTRA
400016
India 
Phone  9326494587  
Fax    
Email  renushilimkar61@gmail.com  
 
Source of Monetary or Material Support  
Dept.of Anaesthesia ,OT complex 3rd floor IPD Of P.D.Hinduja Hospital and Medical Research Centre ,Swatantrya Veer Savarkar road Mahim,Mumbai , Maharashtra,India 400016 
 
Primary Sponsor  
Name  P.D.Hinduja Hospital And Medical Research Center, Mahim 
Address  P.D.Hinduja Hospital And Medical Research Center, Mahim SVS Road,400016  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
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 Shwetal Goraksha  P.D. Hinduja Hospital And Medical Research Centre  Neurosurgical OT 7 ,Dept.of Anaesthesia ,OT complex 3rd floor IPD Of P.D.Hinduja Hospital and Medical Research Centre ,SVS road, Mahim
Mumbai
MAHARASHTRA 
9819570713

shwetalgoraksha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee II P.D.Hinduja Hospital and Medical Research Centre,21st Floor,Building Swatantraya Veer Savarkar Marg,Mumbai 400016  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: D496||Neoplasm of unspecified behavior of brain,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fentanyl Group  Group F (Fentanyl group): Patients will receive Fentanyl as the primary opioid analgesic during anesthesia. In Fentanyl group 60cc syringe will be loaded with 40 cc normal saline and the 10cc will be loaded with 10mcg/kg Fentanyl.Both syringes will be labelled N (narcotic). The anesthetist in group F will start the infusion for 3 minutes(saline in this case). He will also give from narcotic(Fentanyl in this case) 10cc syringe at the dose 0.1ml/kg slowly.  
Intervention  Remifentanil And Fentanyl  Comparison Of Remifentanil And Fentanyl for Induction , Maintenance and Emergence in adult patients undergoing Craniotomy under General Anaesthesia. 
Intervention  Remifentanil Group  Group R -Remifentanil group- Patients will receive Remifentanil as the primary opioid analgesic during anesthesia. In group R 60 cc syringe will be loaded with 50mcg/cc concentration to make a volume of 40cc.(2mg diluted to 40 cc) and a 10cc syringe will be loaded with normal saline.Both syringes will be labelled N (narcotic).The anesthetist on the case for group R will start the infusion at for 3minutes.Anesthesiologist will also administer from 10 cc saline syringe a dose of 0.1ml/kg slowly(saline in this group).  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Age :18-80 Years
Both Male And Non Pregnant Females Patients
ASA I-III
Glassgow Coma Scale 15/15  
 
ExclusionCriteria 
Details  Refusing to participate
Age less than 18 and more than 80 years
BMI more than 35Kg/m2
Pregnant females
Allergy to opioids
ASA IV-V
Emergency surgery

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
1.To compare effects of Remifentanil and Fentanyl on intraoperative hemodynamics . 2. To compare effects of Remifentanil and Fentanyl on recovery.  Mean Rate Pressure Product ,Systolic Blood Pressure ,Diastolic Blood Pressure,Heart Rate,Mean Arterial Presssure at points of maximal stimuli such as
Intubation,Pinning, Incision, Craniotomy,Dural Incision ,Extubation noted at 0min, 1min and 5 min. 
 
Secondary Outcome  
Outcome  TimePoints 
Secondary objectives of the study is to assess the requirement of additional analgesics in immediate post operative period and to see if any complications.  Analgesic requirement post extubation at 0min,10min,20min. 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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   N/A 
Date of First Enrollment (India)   15/11/2025 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan

  3. Who will be able to view these files?
    Response (Others) -  Researchers who are interested in topic and whose use of data has been approved by independent review committee.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [renushilimkar61@gmail.com].

  6. For how long will this data be available start date provided 30-07-2028 and end date provided 29-01-2029?
    Response (Others) -  6 months from the date of publication

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The study titled as Comparison of effects of Remifentanil and Fentanyl on hemodynamics and recovery in patients undergoing elective craniotomy under general anesthesia a prospective observational double blind study aims to determine whether remifentanil is superior to fentanyl in terms of maintaining hemodynamic stability and improving recovery in patients undergoing elective craniotomies. Craniotomy procedures require precise anesthesia management to ensure intraoperative stability and allow for early postoperative neurological assessment. Fentanyl, a commonly used opioid, has a longer half-life which may delay recovery, while remifentanil, due to its ultra short acting nature and unique metabolism, allows for quicker emergence. However, remifentanil provides minimal postoperative analgesia and its use in India has been relatively recent. This study seeks to fill the gap in Indian data by comparing the intraoperative and postoperative effects of these two drugs. The primary objectives are to compare the effects of remifentanil and fentanyl on intraoperative hemodynamics and recovery. The secondary objective is to assess additional analgesic requirements in the immediate postoperative period and observe any complications. This will be a prospective randomized double blind controlled trial conducted at PD Hinduja Hospital and MRC Mahim with a total sample size of 100 patients divided equally into two groups over 18 months. Patients aged 18 to 80 years undergoing elective craniotomy under general anesthesia will be included. After obtaining informed consent and completing a preoperative evaluation, patients will be randomized using computer generated chits into two groups: Group R receiving Remifentanil infusion and saline bolus, and Group F receiving Fentanyl bolus and saline infusion. Anesthesia for both groups will be standardized using Propofol, Sevoflurane and Vecuronium. Hemodynamic parameters will be recorded at specified intervals and postoperative outcomes such as recovery time pain scores and rescue analgesia needs will be evaluated. It is anticipated that remifentanil will offer better hemodynamic control and faster recovery than fentanyl. The study findings may offer insights into optimizing neurosurgical anesthesia practices for Indian patients by highlighting the comparative benefits of these two opioids.

 
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