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

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSir Ganga Ram Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

ASA physical status II/III

laparoscopic and non-laparoscopic surgery of more than 60-minutes duration

Body mass index > 35kg/m2

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Total Body Weight groupActive comparator 1 intervention
Group B: Adjusted Body Weight groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Propofol Maintenance Dose (mg/kg/hour)

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

Time frame
From start of anesthesia till 5- minutes post skin closure

Secondary outcomes

1

Anaesthesia Depth consistency

Percentage of the total valid CLADS time during which the BIS remained + 10% of the target BIS value of 50.

Time frame
From start of anesthesia till 5- minutes post skin closure
2

Performance characteristic of propofol delivery system

It will be determined using the Varvel criteria parameter :median performance error (MDPE). This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. Its just a abstract number

Time frame
From start of anesthesia till 5- minutes post skin closure
3

Performance characteristic of propofol delivery system

It will be determined using the Varvel criteria parameter: median absolute performance error (MDAPE).This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. Its just a abstract number.

Time frame
From start of anesthesia till 5- minutes post skin closure
4

Performance characteristic of propofol delivery system

It will be determined using the Varvel criteria parameter: wobble. This parameter is calculated by the computer software which analyses the intraoperative BIS data. This parameter have no unit of measurement. Its just a abstract number.

Time frame
From start of anesthesia till 5- minutes post skin closure

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.