| CTRI Number |
CTRI/2025/12/098962 [Registered on: 11/12/2025] Trial Registered Prospectively |
| Last Modified On: |
11/12/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
comparison between injection fentanyl and injection remifentanil in controlling increase in heart rate and blood pressure due to laryngoscopy and intubation during anaesthesia for surgery |
|
Scientific Title of Study
|
A randomised double blinded control trial between fentanyl and remifentanil in attenuating hemodynamic response to laryngoscopy and intubation in patients undergoing surgery under general anesthesia. |
| 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 Newstar Syiemiong |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Department of Anesthesiology and critical care
NEIGRIHMS, Mawdiangdiang
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
09856042240 |
| Fax |
|
| Email |
drsyiemiong@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Newstar Syiemiong |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Department of Anesthesiology and critical care
NEIGRIHMS, Mawdiangdiang
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
09856042240 |
| Fax |
|
| Email |
drsyiemiong@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Newstar Syiemiong |
| Designation |
Assistant Professor |
| Affiliation |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Department of Anesthesiology and critical care
NEIGRIHMS, Mawdiangdiang
East Khasi Hills
MEGHALAYA
793018
India |
| Phone |
09856042240 |
| Fax |
|
| Email |
drsyiemiong@gmail.com |
|
|
Source of Monetary or Material Support
|
| North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong |
|
|
Primary Sponsor
|
| Name |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences |
| Address |
Room no 105,Department of Anesthesiology and critical care, NEIGRIHMS, Mawdiangdiang, Meghalaya 793018 |
| Type of Sponsor |
Government medical college |
|
|
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 Syiemiong Newstar |
North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences, Shillong |
4th floor OT complex, DEPARTMENT OF ANAESTHESIOLOGY AND CRITICAL CARE, NEIGRIHMS MAWDIANGDIANG 793018
East Khasi Hills
MEGHALAYA |
09856042240
drsyiemiong@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institution ethics committee, NEIGRIHMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: Z863||Personal history of endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
inj fentanyl |
Inj Fentanyl is the standard of care drug. It will be given as an i.v bolus at a dose of 2 mcg/kg before anesthetic induction. Patient’s hemodynamic parameters along with BIS will be recorded at baseline (TB), one minute before intubation (T0), one minute after intubation (T1) and 3, 5,10 and 15 minutes after intubation (T3, T5, T10, and T15) respectively. Duration of laryngoscopy will also be recorded. |
| Intervention |
inj Remifentanil |
Inj remifentanil will be given in the intervention group with a target control infusion pump choosing Minto model with an effect site concentration (Cet) set at 5 mcg/ml. Patient’s hemodynamic parameters along with BIS will be recorded at baseline (TB), one minute before intubation (T0), one minute after intubation (T1) and 3, 5,10 and 15 minutes after intubation (T3, T5, T10, and T15) respectively. Duration of laryngoscopy will also be recorded. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1. Age- 18 to 65 years
2. ASA I,II and III
3. Both sexes
4. surgeries requiring General anesthesia with orotracheal intubation with direct laryngoscopy |
|
| ExclusionCriteria |
| Details |
1. pregnant and lactating women
2. previous sensitivity to fentanyl, remifentanil, propofol, egg or soya bean
3. patients on beta blockers
4. chronic use of alcohol, sedatives or opioid abuse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| which drug prevents increase in heart rate and blood pressure better |
At baseline and then at minute interval 1,3,5,10 and 15. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| side effects of the medications |
at minute interval 5,15,30,60 post surgery till transfer out from recovery area. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
01/01/2026 |
| 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 - 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
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drsyiemiong@gmail.com].
- For how long will this data be available start date provided 01-01-2026 and end date provided 01-01-2045?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - nil
|
|
Brief Summary
|
study hypothesis: Remifentanil is superior to fentanyl in blunting hemodynamic response to laryngoscopy and intubation during general anesthesia This study aims to see if inj Remifentanil is superior to inj fentanyl in blunting hemodynamic stress response to laryngoscopy ad intubation |