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

Launched by SIR GANGA RAM HOSPITAL · Mar 22, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying how to give a medication called propofol, which is commonly used for anesthesia, to patients who are obese. Researchers want to find out whether dosing based on a patient’s total body weight (TBW) or adjusted body weight (ABW) is more effective when using a special computer-controlled system called a closed-loop anesthesia delivery system (CLADS). This system helps to deliver the right amount of propofol based on how deep a patient is under anesthesia, which could lead to safer and more precise dosing.

To be eligible for this study, participants should be between the ages of 65 and 74, have a body mass index (BMI) greater than 35, and be undergoing surgery that lasts more than 60 minutes. However, individuals with certain health conditions, like heart or lung problems, neurological disorders, or those who are allergic to propofol, cannot participate. Those who join the trial can expect to receive propofol through the advanced delivery system and will be monitored closely during their surgery to help ensure their safety and comfort. This trial aims to improve anesthesia care for obese patients, which is an important step in making surgeries safer.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • 1. ASA physical status II/III
  • 2. laparoscopic and non-laparoscopic surgery of more than 60-minutes duration
  • 3. Body mass index \> 35kg/m2
  • Exclusion Criteria:
  • 1. Cardiovascular disorders (uncontrolled hypertension, Atrio-ventricular block, sinus bradycardia, congenital heart disease, reduced LV compliance \& diastolic dysfunction)
  • 2. Neurological disorders (previous neurosurgery, psychiatric disorders, autonomic nervous system disorders- orthostatic hypotension, transient ischemic attacks)
  • 3. Hepato-renal insufficiency
  • 4. Uncontrolled diabetes mellitus
  • 5. Known allergy/hypersensitivity to study drug
  • 6. Pulmonary dysfunction (restrictive /obstructive lung disease)
  • 7. Acute/chronic drug dependence/substance abuse

About Sir Ganga Ram Hospital

Sir Ganga Ram Hospital is a premier multi-specialty healthcare institution located in New Delhi, India, renowned for its commitment to delivering high-quality patient care and advancing medical research. Established in 1954, the hospital is equipped with state-of-the-art facilities and a team of highly skilled professionals dedicated to clinical excellence. As a clinical trial sponsor, Sir Ganga Ram Hospital actively engages in innovative research initiatives aimed at improving treatment outcomes and enhancing patient safety. Through its robust ethical framework and adherence to regulatory standards, the hospital fosters a collaborative environment for clinical research, contributing to the global medical community's efforts in developing effective therapies and interventions.

Locations

New Delhi, Delhi, India

Patients applied

0 patients applied

Trial Officials

Goverdhan D Puri, MD, PhD

Study Director

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

Jayashree Sood, MD, FFRCA, PGDHHM, FICA

Study Chair

Sir Ganga Ram Hospital, New Delhi, INDIA

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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