| CTRI Number |
CTRI/2025/08/092762 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
09/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the dosage of Propofol required for induction (to make patients unconscious or sleep before surgery) with the pre - induction administration of either of the two opioids - Nalbuphine or Fentanyl, and to compare which drug provides better emodynamic stability. |
|
Scientific Title of Study
|
A Comparative Evaluation between Nalbuphine and Fentanyl with respect to induction dose of Propofol for patients undergoing Laparoscopic Cholecystectomy under General Anaesthesia in a Tertiary Care Hospital in Sikkim - A Double Blinded Randomised Controlled Trial |
| 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 Deepanshi Agrawal |
| Designation |
Junior Resident |
| Affiliation |
Sikkim Manipal Institue of Medical Sciences |
| Address |
Department Classroom, Level 6, Main OT Complex
Department of Anaesthesia, Central Referral Hospital, 5th Mile, Tadong, Gangtok, East Sikkim
East
SIKKIM
737102
India |
| Phone |
9332610237 |
| Fax |
|
| Email |
honeyagarwal8861@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sofia Batool |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department Classroom, Level 6, Main OT Complex
Department of Anaesthesia, Central Referral Hospital, 5th Mile, Tadong, Gangtok, East Sikkim
East
SIKKIM
737102
India |
| Phone |
9733005809 |
| Fax |
|
| Email |
sofia.b@smims.smu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sofia Batool |
| Designation |
Associate Professor |
| Affiliation |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department Classroom, Level 6, Main OT Complex
Department of Anaesthesia, Central Referral Hospital, 5th Mile, Tadong, Gangtok, East Sikkim
SIKKIM
737102
India |
| Phone |
9733005809 |
| Fax |
|
| Email |
sofia.b@smims.smu.edu.in |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia, Central Referral Hospital, 5th Mile, Tadong, Gangtok, East Sikkim 737102 |
|
|
Primary Sponsor
|
| Name |
Sikkim Manipal Institute of Medical Sciences |
| Address |
Department of Anaesthesia, Central Referral Hospital, 5th mile, Tadong, Gangtok, East Sikkim 737102 |
| 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 Deepanshi Agrawal |
Central Referral Hospital |
Department classroom Level 6, Main OT Complex, Department of Anaesthesia, 5th Mile, Tadong, Gangtok, East Sikkim
East
SIKKIM |
9332610237
honeyagarwal8861@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SMIMS Institution Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A comparative evaluation between nalbuphine and fentanyl on induction dose of propofol |
After shifting patient on ot table and attaching monitors, baseline vitals will be recorded, patient will be pre-oxygenated and inj. Glycopyrrolate IV will be given, then either of the study drugs will be administered intravenously and after 5 mins of receiving it, inj. Propofol @ 1ml/3sec will be started intravenously. Induction will be complete with loss of verbal response from patient. laryngoscopy and intubation will be performed after 1min of giving inj. Succinylcholine IV. immediately after intubation, haemodynamic parameters will be monitored for every min till 10 mins to evaluate stress response. Rest of the procedure will be carried according to institutional protocol. The procedure of recording vitals will be completed within 10 mins of intubation. |
| Comparator Agent |
A comparitive evaluation between nalbuphine and fentanyl on induction dose of propofol. |
N/A |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade 1 and 2
patients undergoing elective laparoscopic cholecystectomy and providing written consent |
|
| ExclusionCriteria |
| Details |
ASA Grade 3 and 4
Pregnant females
Patient refusal
Patients allergic to or addicted to any drug used in trial ( nalbuphine, fentanyl or propofol) |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Nalbuphine will be more effective than Fentanyl in reducing the induction dose of Propofol |
Nalbuphine will be more effective than Fentanyl in reducing the induction dose of Propofol which will be assessed after administering the propofol in the intra-operative period. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess which study drug helps in attenuating stable stress response (HR, BP , MAP & sPo2) to laryngoscopy & intubation. |
After laryngoscopy & intubation, vitals will be monitored for every min for next 10 minutes & will be assessed within 24 hrs intraoperatively & post operatively. |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
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 4 |
|
Date of First Enrollment (India)
|
20/08/2025 |
| 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="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 - NO
|
|
Brief Summary
|
A comparative evaluation between nalbuphine and fentanyl with respect to induction dose of propofol for patients undergoing laparoscopic cholecystectomy under general anaesthesia. The objective of this study is to compare the dosage of propofol required for induction with pre - induction administration of two study drugs - nalbuphine and fentanyl and secondarily to assess the attenuation of stress response ( HR, BP, MAP, Spo2) to laryngoscopy and intubation between the two study drugs and lastly to assess any adverse effects intra- or post- operatively. |