Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System

NCT05305313 | Recruiting Phase 4

• 1 other identifier: EC/01/22/1992
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Anesthesia; Propofol; Obesity, Morbid

Outcome Measures

Primary Outcomes (1)

• Propofol Maintenance Dose (mg/kg/hour)

  Propofol required for maintenance of anaesthesia based on total body weight versus adjusted body weight

  From start of anesthesia till 5- minutes post skin closure

Secondary Outcomes (11)

• Anaesthesia Depth consistency

  From start of anesthesia till 5- minutes post skin closure

• Performance characteristic of propofol delivery system

  From start of anesthesia till 5- minutes post skin closure

• Performance characteristic of propofol delivery system

  From start of anesthesia till 5- minutes post skin closure

• Performance characteristic of propofol delivery system

  From start of anesthesia till 5- minutes post skin closure

• Performance characteristic of propofol delivery system

  From start of anesthesia till 5- minutes post skin closure

Study Arms (2)

Total Body Weight group

ACTIVE COMPARATOR

Anesthesia will be induced and maintained with Propofol administered by CLADS which will be set to deliver Propofol according to total body weight (TBW). A BIS-value of 50 will be used as the target for induction and maintaenance of anesthesia.

Drug: Propofol

Adjusted Body Weight group

ACTIVE COMPARATOR

Anesthesia will be induced and maintained with Propofol administered by CLADS which will be set to deliver Propofol according to adjusted body weight (ABW). A BIS-value of 50 will be used as the target for induction and maintenance of anesthesia.

Drug: Propofol

Interventions

Propofol DRUG

Propofol delivery will be controlled using automated closed loop anaesthesia delivery system which will control propofol delivery rate to consistent anaesthetic depth (BIS-50) feedback from the patient.

Total Body Weight group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA physical status II/III
• laparoscopic and non-laparoscopic surgery of more than 60-minutes duration
• Body mass index \> 35kg/m2

You may not qualify if:

• Cardiovascular disorders (uncontrolled hypertension, Atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance \& diastolic dysfunction)
• Neurological disorders (previous neurosurgery, psychiatric disorders, autonomic nervous system disorders- orthostatic hypotension, transient ischemic attacks)
• Hepato-renal insufficiency
• Uncontrolled diabetes mellitus
• Known allergy/hypersensitivity to study drug
• Pulmonary dysfunction (restrictive /obstructive lung disease)
• Acute/chronic drug dependence/substance abuse

Sponsors & Collaborators

• Sir Ganga Ram Hospital: lead

Study Sites (1)

Nitin Sethi

New Delhi, National Capital Territory of Delhi, 110060, India

RECRUITING

MeSH Terms

Conditions

Obesity, Morbid

Interventions

Propofol

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Goverdhan D Puri, MD, PhD

  Post Graduate Institute of Medical Education & Research, Chandigarh, India

  STUDY DIRECTOR

• Jayashree Sood, MD, FFRCA, PGDHHM, FICA

  Sir Ganga Ram Hospital, New Delhi, INDIA

  STUDY CHAIR

Central Study Contacts

Nitin Sethi, DNB

CONTACT

+919717494498; nitinsethi77@yahoo.co.in

Amitabh Dutta, MD, PGDHR

CONTACT

00919810873804; duttaamitabh@yahoo.co.in

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient will be blinded to the type of anaesthesia intervention. The attending anaesthesiologist will however not be blinded to the technique utilized to administer GA and recovery immediately after extubation inside the OR. The postoperative patient recovery profile will be evaluated by an independent assessor blinded to the technique of GA.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Forty six- patients of either sex, and schedule for laparoscopic and non-laparoscopic surgery of more than 60-minutes duration will be randomly divided into two groups of 23 each patients: Group-I \[TBW group, n=23\]: Patients in this group will receive maintenance propofol calculated using total body weight (TBW). Group-II \[ABW group, n=23\]: Patients in this group will receive maintenance propofol calculated using adjusted body weight (ABW).

Study Record Dates

• First Submitted: March 22, 2022
• First Posted: March 31, 2022
• Study Start: April 19, 2022
• Primary Completion (Estimated): November 4, 2027
• Study Completion (Estimated): November 10, 2027
• Last Updated: April 27, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)