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.

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 - NIL

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/08/092762

Enrollment

168

Registered

2025-08-11

Start date

Unknown

Completion date

Unknown

Last updated

2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K801- Calculus of gallbladder with othercholecystitis

Interventions

Intervention1: 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, pati

Eligibility

Inclusion criteria

Inclusion criteria: ASA Grade 1 and 2 patients undergoing elective laparoscopic cholecystectomy and providing written consent

Exclusion criteria

Exclusion criteria: ASA Grade 3 and 4 Pregnant females Patient refusal Patients allergic to or addicted to any drug used in trial ( nalbuphine, fentanyl or propofol)

Design outcomes

Primary

Measure	Time frame
Nalbuphine will be more effective than Fentanyl in reducing the induction dose of PropofolTimepoint: 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

Measure	Time frame
To assess which study drug helps in attenuating stable stress response (HR, BP , MAP & sPo2) to laryngoscopy & intubation.Timepoint: After laryngoscopy & intubation, vitals will be monitored for every min for next 10 minutes & will be assessed within 24 hrs intraoperatively & post operatively.	—

Countries

India

Contacts

Public ContactDr Sofia Batool

Sikkim Manipal Institute of Medical Sciences

sofia.b@smims.smu.edu.in9733005809

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026