| CTRI Number |
CTRI/2025/02/080283 [Registered on: 10/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
To Determine the Effect of a drug, Remifentanil on the Onset Time of a muscle relaxant named Rocuronium using a Monitor in Patients Undergoing General Anaesthesia |
|
Scientific Title of Study
|
To Determine the Effect of Remifentanil Dose on the Onset Time of Rocuronium Using TOF (Train-of-Four) Neuromuscular Monitoring in Patients Undergoing General Anaesthesia |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Avni Sharma |
| Designation |
Post Graduate Trainee |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Department of Anaesthesiology, Room Number 230, KPC Medical College & Hospital, Jadavpur, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
8820236496 |
| Fax |
|
| Email |
avni.v.sharma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Subrata Ray |
| Designation |
Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Department of Anaesthesiology, Room Number 230, KPC Medical College & Hospital, Jadavpur, Kolkata
Kolkata
WEST BENGAL
700032
India |
| Phone |
9674330016 |
| Fax |
|
| Email |
raysubrata62@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Subrata Ray |
| Designation |
Professor |
| Affiliation |
KPC Medical College & Hospital |
| Address |
Department of Anaesthesiology, Room Number 230, KPC Medical College & Hospital, Jadavpur, Kolkata
WEST BENGAL
700032
India |
| Phone |
9674330016 |
| Fax |
|
| Email |
raysubrata62@gmail.com |
|
|
Source of Monetary or Material Support
|
| KPC Medical College and Hospital
1F, Raja S.C. Mullick Road, Jadavpur, Kolkata-700032, West Bengal, India |
|
|
Primary Sponsor
|
| Name |
KPC Medical College and Hospital |
| Address |
1F, Raja S.C. Mullick Road, Jadavpur, Kolkata-700032, West Bengal, India |
| Type of Sponsor |
Private 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 Subrata Ray |
KPC Medical College & Hospital |
Department of Anaesthesiology, Room no. 230, KPC Medical College & Hospital, 1F, Raja S.C. Mullick Road, Jadavpur
Kolkata
WEST BENGAL |
9674330016
raysubrata62@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (Registration No. ECR/306/Inst/WB/2013) KPC MEDICAL COLLEGE & HOSPITAL JADAVPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Normal Saline (Group S) |
25 patients will be given 0.9% Normal Saline infusion during induction. This group will be given Remifentanil 0.5 micrograms/kg/min after intubation. |
| Intervention |
Remifentanil (Group R 0.5) |
25 patients will be given Remifentanil infusion at a dose of 0.5 micrograms/kg/minute during induction. |
| Intervention |
Remifentanil (Group R 1.0) |
25 patients will be given Remifentanil infusion at a dose of 1 microgram/kg/minute during induction. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients planned for any surgery requiring endotracheal intubation under general anaesthesia
2. Patients aged between 18 to 60 years
3. Patients with ASA grade I and II
4. Patients giving informed written consent
|
|
| ExclusionCriteria |
| Details |
1. Patients with a history of cardiac, pulmonary, renal, hepatic, cerebral or neuromuscular disease
2. Having an allergy to opioids or propofol
3. Chronic alcohol or drug abuse
4. A body mass index of 30 kg/m2
5. Pregnant patients
6. Age less than 18 years or more than 60 years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the times taken to reach TOF 0 and TOFR 25% in groups R 0.5, R1 and S and to compare the results and therefore determine the optimal dose of Remifentanil infusion.
|
TOF baseline, TOFR 25% and TOF 0 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To monitor hemodynamic response to laryngoscopy and intubation. |
Recorded at Baseline, at TOFR 25% and TOF 0 |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
17/02/2025 |
| 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="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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 - NO
|
|
Brief Summary
|
The sympathetic surge of hypertension and tachycardia following laryngoscopy and intubation are well known and extensively described. Opioids or other intravenous and inhalational agents are used to attenuate this potentially harmful effect. Opioids potentiate the action of muscle relaxants. Recently, Remifentanil was reported to have conflicting effect on onset time of Rocuronium.We want to study the effect of two different doses of Remifentanil as given by infusion, on the time taken to onset of action of Rocuronium for endotracheal intubation by monitoring with Train-of-Four (TOF). |