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

RecruitingPhase 4Ages 18 Years - 65 YearsAllSir Ganga Ram Hospital
NCT05305313 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
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
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What it tests

  • Propofol
  • Propofol
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Where

1 site
Nitin Sethi
New Delhi, India
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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