| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- 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.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response - Proposals should be directed to [renushilimkar61@gmail.com].
- 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
- 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. |