A study to evaluate how effective it is to add Sufentanil to Propofol in intravenous anaesthesia for patients undergoing laparoscopic cholecystectomy

Phase 4

• Conditions: To compare and evaluate the effectiveness of different concentrations of Sufentanil mixed in Propofol infusion on perioperative haemodynamic parameters, recovery times and postoperative analgesia in total intravenous anaesthesia (TIVA) for patients undergoing laparoscopic cholecystectomy.

• Registration Number: CTRI/2008/091/000182
• Lead Sponsor: DrM Subrahmanyam

Brief Summary

This study is a randomised double blind study that evaluates the effectiveness of different concentrations of Sufentanil mixed in Propofol infusion in total intravenous anaesthesia (TIVA) for laparoscopic cholecystectomy. The objectives are to compare and evaluate perioperative haemodynamic parameters, recovery times and postoperative analgesia among 60 adult patients divided into three groups of 20 each receiving TIVA using Propofol infusion with or without Sufentanil. It was conducted over a period of 18 months at Global hospitals, Hyderabad. We conclude that both concentrations of Sufentanil added to Propofol infusion, 1 mcg/ml (Group S1) and 2 mcg/ml (Group S2), provide stable intraoperative haemodynamics and good postoperative analgesia. Recovery time was prolonged in Group S2 but it may not be clinically important (7 minutes). Hence,we conclude that both concentrations of Sufentanil achieve the goals of stable haemodynamics without a clinically significant prolongation of recovery time but the 24- hour postoperative analgesia was better in Group S2.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

• Adult patients aged between 18 and 65 years of both sexes, of American Society of Anaesthesiologists (ASA) physical status I or II with airway status.
• Mallampati scores 1 and 2, posted for elective laparoscopic cholecystectomy.

Exclusion Criteria

Age less than 18 years or more than 65 years, body weight more than 90 kgs, ASA physical status III to V, Mallampati scores 3 and 4 of airway, history of hypertension, history of coronary artery disease, history of long term analgesic use, history of psychiatric disorders, patients with severe hepatic or renal dysfunction and patients in whom NSAIDS are contraindicated.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recovery time from anaesthesia	Towards the end of anaesthesia for each patient undergoing surgery

Trial Locations

Locations (1)

Global Hospitals; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Global Hospitals

🇮🇳Hyderabad, ANDHRA PRADESH, India

Dr. M. Subrahmanyam

Principal investigator

9246160977

msubrah@gmail.com