Status:
RECRUITING
Evaluation of Propofol Dosing Based on Total Body Weight Using Closes-loop Anaesthesia Delivery System
Lead Sponsor:
Sir Ganga Ram Hospital
Conditions:
Obesity, Morbid
Anesthesia
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
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 inducti...
Detailed Description
Propofol is the most used intravenous agent for induction and maintenance of anaesthesia as part of total intravenous anaesthesia (TIVA) regimen. In the morbidly obese, various factors, such as, incr...
Eligibility Criteria
Inclusion
- ASA physical status II/III
- laparoscopic and non-laparoscopic surgery of more than 60-minutes duration
- Body mass index \> 35kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 10 2026
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT05305313
Start Date
April 19 2022
End Date
November 10 2026
Last Update
October 29 2024
Active Locations (1)
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1
Nitin Sethi
New Delhi, National Capital Territory of Delhi, India, 110060