Evaluating Propofol Dosing in Obese Patients
Evaluation of Propofol Dosing Based on Total Body Weight Versus Adjusted Body Weight in Obese Patients Receiving Total Intravenous Anaesthesia With Automated Closed-Loop Anaesthesia Delivery System: A Randomized Controlled Study
This study tests whether using total body weight or adjusted body weight for dosing propofol can help keep morbidly obese patients safely anesthetized during long surgeries.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 46 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Sir Ganga Ram Hospital Academic / other |
| Locations | 1 site (New Delhi, National Capital Territory of Delhi) |
| Trial ID | NCT05305313 on ClinicalTrials.gov |
What this trial studies
This study evaluates the dosing of propofol, an intravenous anesthetic, based on total body weight in morbidly obese patients undergoing surgery. It aims to address the challenges of drug accumulation and potential overdosing that can occur when using standard dosing methods. The study will compare the effectiveness of dosing based on total body weight versus adjusted body weight for maintaining anesthesia during procedures lasting over 60 minutes. By focusing on the unique pharmacokinetics in obese patients, the study seeks to improve anesthesia management and patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are morbidly obese patients (BMI > 35 kg/m2) scheduled for laparoscopic or non-laparoscopic surgeries lasting more than 60 minutes.
Not a fit: Patients with cardiovascular, neurological, or pulmonary disorders, as well as those with uncontrolled diabetes or allergies to propofol, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to safer and more effective anesthesia protocols for morbidly obese patients.
How similar studies have performed: While propofol dosing based on total body weight has been researched, this specific approach using adjusted body weight for morbidly obese patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
New Delhi, National Capital Territory of Delhi
- Nitin Sethi — New Delhi, National Capital Territory of Delhi, India (Recruiting)
Study contacts
- Study coordinator: Nitin Sethi, DNB
- Email: nitinsethi77@yahoo.co.in
- Phone: +919717494498
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.