Actively Recruiting
Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System
Led by Sir Ganga Ram Hospital · Updated on 2026-04-27
46
Participants Needed
1
Research Sites
290 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The pharmacokinetic profile of various drugs is altered in obese patients especially those administered by the intravenous route. Propofol is the commonly used intravenous anesthetic agent for induction and maintenance of anaesthesia as part of total intravenous anaesthesia (TIVA) regimen. A major concern with propofol dosing based on total body weight (TBW) in obese patients is disproportionate drug administration leading to undue drug accumulation in body with a potential to overdosing, delayed recovery from anaesthesia, and adverse hemodynamic outcome. Studies on propofol dosing based on various weight scalars have recommended that lean body weight (LBW) should be used for calculating bolus dose during anaesthesia induction and TBW or adjusted body weight (ABW) for arriving at an infusion dose required for maintenance of anesthesia. Although propofol delivery based on dose calculated by TBW has been well researched the evidence for propofol delivery based on dose calculated by ABW is lacking. Recent advance in the delivery of propofol has been the development of computer controlled anaesthesia delivery systems. These devices deliver propofol based on patient's frontal cortex electrical activity as determined by bispectral index (BIS). Evaluation of anaesthesia delivery by these systems has shown that they deliver propofol and maintain depth of anaesthesia with far more precision as compared to manual administration. One such indigenously developed computer controlled anaesthesia delivery system is the closed loop anesthesia delivery system (CLADS). CLADS functions on control of processed EEG response parameter captured from anesthetized patients with the help of a BIS- monitor, which is continuously fed into an automated drug infusion pump. The infusion pump then accordingly delivers the anesthetic drug to the patients based on pharmacodynamic requirements. The investigators plan to evaluate the propofol maintenance dose requirement based on TBW versus ABW using CLADS for propofol delivery.
CONDITIONS
Official Title
Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System
Who Can Participate
Eligibility Criteria
You may qualify if you...
- ASA physical status II or III
- Undergoing laparoscopic or non-laparoscopic surgery lasting more than 60 minutes
- Body mass index (BMI) greater than 35 kg/m2
You will not qualify if you...
- Uncontrolled cardiovascular disorders such as hypertension, atrioventricular block, sinus bradycardia, congenital heart disease, or reduced left ventricular compliance and diastolic dysfunction
- Neurological disorders including previous neurosurgery, psychiatric disorders, or autonomic nervous system issues like orthostatic hypotension or transient ischemic attacks
- Liver or kidney failure
- Uncontrolled diabetes mellitus
- Known allergy or hypersensitivity to propofol
- Pulmonary dysfunction such as restrictive or obstructive lung disease
- Acute or chronic drug dependence or substance abuse
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nitin Sethi
New Delhi, National Capital Territory of Delhi, India, 110060
Actively Recruiting
Research Team
N
Nitin Sethi, DNB
CONTACT
A
Amitabh Dutta, MD, PGDHR
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
BASIC_SCIENCE
Number of Arms
2
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