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Evaluation of Propofol Dosing Based on Total Body Weight Versus Adjusted Body Weight in Obese Patients Receiving Total Intravenous Anaesthesia Using an Automated Closed-Loop Anaesthesia Delivery System: A Randomized Controlled Study
Led by Sir Ganga Ram Hospital · Updated on 2026-04-27
46
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating how different methods of calculating propofol dosing affect anesthesia in obese patients. Propofol is a common intravenous anesthetic used for induction and maintenance during surgery. Obesity changes how drugs are processed in the body, making dosing challenging. This study compares dosing based on total body weight (TBW) to adjusted body weight (ABW) to see which approach better controls anesthesia without overdosing or delayed recovery. The study uses a computer-controlled closed-loop anesthesia delivery system (CLADS) that adjusts propofol infusion based on brain electrical activity measured by bispectral index (BIS). Patients are randomly assigned to receive propofol dosing calculated either by TBW or ABW during surgery lasting more than 60 minutes. A BIS target value of 50 guides anesthesia depth, with propofol delivered continuously via an automated pump during the procedure. Participants will undergo standard assessments including monitoring of anesthesia depth, heart rate, blood pressure, and recovery after surgery. The primary outcome is the maintenance dose of propofol required during anesthesia. Secondary outcomes include consistency of anesthesia depth, system performance, early recovery, sedation levels, and intraoperative awareness. The study involves adult obese patients up to age 65 undergoing laparoscopic or non-laparoscopic surgery. Safety and drug effects are closely monitored from anesthesia start until 48 hours after surgery.
CONDITIONS
Brief 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 greater than 35 kg/m2
- Age between 18 and 65 years
You will not qualify if you...
- Cardiovascular disorders including uncontrolled hypertension, atrioventricular block, sinus bradycardia, congenital heart disease, or reduced left ventricular compliance and diastolic dysfunction
- Neurological disorders such as previous neurosurgery, psychiatric disorders, or autonomic nervous system disorders like orthostatic hypotension or transient ischemic attacks
- Liver or kidney insufficiency
- Uncontrolled diabetes mellitus
- Known allergy or hypersensitivity to propofol
- Pulmonary dysfunction including restrictive or obstructive lung disease
- Acute or chronic drug dependence or substance abuse
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - From start of anesthesia until 5 minutes after skin closure
Participants receive anesthesia induced and maintained with Propofol administered by an automated closed-loop anesthesia delivery system (CLADS), which controls propofol delivery rate to maintain a consistent anesthetic depth (BIS=50). Dosing is based on either total body weight (TBW) or adjusted body weight (ABW) depending on group assignment.
1 anesthesia session (in-person)
Duration - Up to 48 hours post-anesthesia
Participants are monitored for early recovery from anesthesia, postoperative sedation, and intraoperative awareness.
Visits or assessments up to 48 hours after anesthesia
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
A
Amitabh Dutta, MD, PGDHR
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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