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A study to compare the machine controlled with human controlled changes in propofol dose for patients undergoing laproscopic cholecystectomy under general anaesthesia

COMPARATIVE EVALUATION OF TARGET CONTROLLED VERSUS MANUAL INFUSION OF PROPOFOL IN PATIENTS UNDERGOING LAPAROSCOPIC CHOLECYSTECTOMY UNDER GENERAL ANAESTHESIA

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/04/065417
Enrollment
20
Registered
2024-04-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-04-29

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

Conditions

Health Condition 1: - Health Condition 2: K800- Calculus of gallbladder with acutecholecystitis Health Condition 3: K802- Calculus of gallbladder without cholecystitis

Interventions

Intervention1: Target controlled propofol infusion: Dose- Initial target plasma concentration set at 4µg/ml Frequency- The target plasma concentration will be changed according to the BIS values (l

Sponsors

Maulana Azad Medical College and associated hospitals
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Age 18 – 65 years 2. ASA physical health status 1 and 2

Exclusion criteria

Exclusion criteria: 1.Cardiac, liver or kidney disease 2. History of drug or alcohol abuse 3. Allergy to Propofol 4. Allergy to egg or soya bean oil 5. Regular intake of sedative or hypnotic or psychiatric medication 6. Obesity (BMI >30kg/m2)

Design outcomes

Primary

MeasureTime frame
Time to reach a Modified Aldrete score of 10Timepoint: Time in minutes to reach a Modified Aldrete score of 10 in the post operative period—

Secondary

MeasureTime frame
1.Induction time 2.Recovery time 3.Total amount of propofol and fentanyl used 4.Percentage of time when BIS value will be between 40 and 60 5.Hemodynamic Variability ( MAP, HR) requiring intervention Timepoint: 1.Induction time- Time in minutes from start of induction till loss of verbal response 2.Recovery time – time in minutes from discontinuation of propofol infusion to eye opening on command, tracheal extubation and orientation to time and place. 3. Total amount of propofol used from induction till recovery—

Countries

India

Contacts

Public ContactDr Lalatendu Das

Maulana Azad Medical College and associated hospitals

munisha.agarwal@gmail.com9968604216

Outcome results

None listed

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