Influence of Obesity on Propofol Pharmacokinetics During Cardiopulmonary Bypass

Influence of Obesity on Propofol Pharmacokinetics During Cardiac Surgeries Using Cardiopulmonary Bypass: Derivation of a Pharmacokinetic Model

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02477982

Enrollment

Registered

2015-06-23

Start date

2012-12-31

Completion date

2014-08-31

Last updated

2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Obesity

Keywords

Propofol, Cardiopulmonary Bypass, Pharmacokinetics, Obesity

Brief summary

The primary objective of this study is to develop a descriptive and predictive pharmacokinetics model propofol disposition during cardiopulmonary bypass (CPB) in obese and lean patients.

Detailed description

Anaesthesia maintenance upon initiation of CPB will be achieved by propofol (1%) bolus (1 mg/kg TBW) immediately followed by 2 mg/kg TBW/hr infusion that will be continued till weaning from CPB. During CPB an additional propofol bolus doses can be administered to prevent awareness according to the clinical judgment of the responsible anaesthesiologist. Any additional doses given and their timings will be recorded. Blood samples of 2 ml each will be collected from the arterial line of CPB machine until the end of CPB then from sub-clavin arterial catheter routinely inserted in such surgeries. Sampling process will follow the following schedule; at baseline prior to dosing, followed by samples at 1, 3, 5,7 min after the propofol bolus dose, then every 20 minutes during propofol infusion, just before discontinuation of the propofol infusion and at 1, 3, 5, 7, 10, 20, 30, 60 minutes after the end of infusion. In addition, just before any rescue propofol dose administration, an unscheduled sample will be withdrawn

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* BMI ≤ 25 kg/m2 or ≥ 30 kg/m2. * Propofol based maintenance of anaesthesia during CPB.

Exclusion criteria

* Pregnant women or lactating mothers. * Renal (serum creatinine concentration\>1.5 or creatinine Cl ≤ 30 ml/min) or hepatic disorders (total bilirubin \>1.5 or ≥ 2 fold increase in alanine transferase (ALT) or aspartate transferase (AST). * Systemic infections. * Hypoalbuminemia (defined as albumin \<3.5 gm/dL). * Known history of alcohol or drug abuse. * Administration of aspirin on the day of surgery or warfarin within 7 days preceding surgery

Design outcomes

Primary

Measure	Time frame
Clearance (Cl/)	intraoperative
volume of distribution of first compartment (V1)	intraoperative
Clearance from first to second compartment (Q1)	intraoperative
volume of distribution of second compartment (V1)	intraoperative

Outcome results