| CTRI Number |
CTRI/2025/07/091893 [Registered on: 28/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A Study on How the Timing Between Fentanyl and Thiopentone Affects Anaesthesia Dose Requirements in Adults |
|
Scientific Title of Study
|
Comparison of different time intervals between fentanyl and thiopentone on entropy guided induction dose of thiopentone in adult patients under 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 |
Dr. Anjali Yadav |
| Designation |
Post Graduate Resident |
| Affiliation |
Abvims and Dr. rml hospital |
| Address |
House no. 501
Sector 22b, Near Anand farms
122015
Gurugram
India
Gurgaon
HARYANA
122015
India |
| Phone |
9518415457 |
| Fax |
|
| Email |
anjaliyadav3180@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sandeep Kumar |
| Designation |
Associate Professor |
| Affiliation |
Abvims and Dr. rml hospital |
| Address |
Room no.301, 3rd floor
Department of Anaesthesia
Abvims and Dr.rml hospital
New Delhi,
110001
New Delhi
DELHI
110001
India |
| Phone |
9868910835 |
| Fax |
|
| Email |
drsandeeprml@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Sandeep Kumar |
| Designation |
Associate Professor |
| Affiliation |
Abvims and Dr. rml hospital |
| Address |
Room no.301, 3rd floor
Department of Anaesthesia
Abvims and Dr.rml hospital
New Delhi
110001
New Delhi
DELHI
110001
India |
| Phone |
9868910835 |
| Fax |
|
| Email |
drsandeeprml@gmail.com |
|
|
Source of Monetary or Material Support
|
| Abvims and Dr.rml hospital, Baba Kharak Singh Marg, Near gurudwara bangla sahib, Connaught place, New delhi 110001 |
|
|
Primary Sponsor
|
| Name |
Dr Anjali yadav |
| Address |
House no.501
sector 22b, near anand farms
122015 |
| Type of Sponsor |
Other [Self] |
|
|
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 Anjali yadav |
Abvims and Dr. rml hospital |
Room no.301, 3rd floor
Department of Anaesthesia
Abvims and Dr.rml hospital
New Delhi
110001
New Delhi
DELHI |
9518415457
anjaliyadav3180@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and DR RML HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z018||Encounter for other specified special examinations, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Fentanyl 2 µg per kg followed by thiopentone after 3 minutes |
In Group B, patients will receive intravenous fentanyl 2 µg per kg as a bolus. After a time interval of 3 minutes, intravenous thiopentone (2.5 percent) will be given slowly in 25 mg aliquots until SE and RE values fall below 60. All other procedures, monitoring, vital recording, airway management, neuromuscular blockade, and postoperative follow-up will be as described in Group A.
|
| Comparator Agent |
fentanyl 2 µg per kg followed by thiopentone after 6 minutes |
In Group C, intravenous fentanyl 2 µg per kg will be administered first. After a time interval of 6 minutes, intravenous thiopentone (2.5 percent) will be given gradually in 25 mg increments until the entropy values (SE and RE) fall below 60. Monitoring, vital recording schedule, drug management, airway handling, and postoperative follow-up will be identical to other groups. |
| Intervention |
Fentanyl 2 µg per kg followed immediately by thiopentone |
Patients in Group A will receive intravenous fentanyl at a dose of 2 µg per kg as a bolus. Immediately after fentanyl administration, intravenous thiopentone (2.5 percent) will be administered in a graded manner (25 mg aliquots) until both the State Entropy (SE) and Response Entropy (RE) values fall below 60. The dose of thiopentone required and the time taken to reach target entropy levels will be recorded. Standard monitoring including ECG, NIBP, pulse oximetry, and entropy will be used. Oxygen saturation, heart rate, and blood pressure will be recorded every 2 minutes for 10 minutes, and then every 5 minutes until 30 minutes. Additional thiopentone (1 mg per kg) will be given if movement is noted during airway handling. Rocuronium 0.6 mg per kg will be administered after confirming mask ventilation. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade: American society of Anaesthesiologists physical status grade I- II scheduled for
elective surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
1.Known allergic reactions to sulpha group drugs. 2.Patients on drugs which are likely to interfere with induction agent or hemodynamic parameters. 3.Neurology or neurosurgery patients.
4.Patients posted for emergency surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total dose of thiopentone required for induction of anaesthesia in the groups. |
0- 10 minutes after thiopentone administration. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.The incidence of abnormal movement after the initial dose of thiopentone.
2.The incidence of heart rate, oxygen saturation, and blood pressure variations in these patients. |
1.0-10 minutes after thiopentone administration.
2.Every 2 minutes from 0 to 10 minutes after thiopentone administration and thereafter
every 5 minutes from 10 to 30 minutes post-induction. |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/08/2025 |
| 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="5"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study aims to evaluate how varying time interval between the administration of fentanyl and thiopentone affects the induction dose of thiopentone required, as guided by entropy monitoring, in adult patients undergoing general anaesthesia. By comparing different time gaps between these two drugs, the study seeks to optimise drug dosing for safer and more effective anaesthesia induction. Secondary outcomes include the incidence of abnormal movements and changes in vital parameters such as heart rate, oxygen saturation, and blood pressure during induction. |