This study involved patients having keyhole gallbladder surgery under sevoflurane anaesthesia and compared how long it took to remove their breathing tubes after surgery to see how quickly they recovered from anaesthesia

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2025/06/089416
• Lead Sponsor: Dr Lalhmangaihzuali

Brief Summary

This study is a prospective, randomized comparative study aimed at evaluating the difference in tracheal extubation time between bispectral index monitoring and end-tidal anaesthetic gas concentration monitoring in adult patients undergoing laparoscopic cholecystectomy under sevoflurane-based general anaesthesia. Sixty patients aged 18 to 60 years, classified as ASA grade 1 or 2, will be randomly assigned to either BIS or ETAG groups. Anaesthetic depth will be maintained using BIS values 40 to 60 or ETAG MAC levels 0.7 to 1.3. Extubation time will be recorded as the primary outcome. Secondary outcomes include comparisons of hemodynamic parameters, recovery time and intraoperative awareness. This study seeks to determine which monitoring method facilitates quicker and safer emergence from anaesthesia.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2025-06-23
• Study Start: 2025-07-07

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

ASA grade 1 or 2 Surgery duration of 30 to 60 minutes.

Exclusion Criteria

BMI>30kg/m2 Psychiatric disorders Epilepsy On chronic hypnotics/sedatives Renal disease Active neurological disease Neuromuscular disease.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Tracheal extubation time (in minutes) in BIS and ETAG group	60 minutes

Secondary Outcome Measures

Name	Time	Method
Haemodynamic parameters in BIS & ETAG group	At 0 & every 5 minutes till extubation of tracheal tube
Recovery time in BIS & ETAG group	At 0 minute & every 5 minutes in the Post Anaesthesia Care Unit
Intraoperative awareness in BIS & ETAG group	Within 12 to 24 hours after surgery

Trial Locations

Locations (1)

ESI-PGIMSR; 🇮🇳 West, DELHI, India

ESI-PGIMSR

🇮🇳West, DELHI, India

Lalhmangaihzuali

Principal investigator

07085645121

lalhmangaihzualigangte@gmail.com