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Completed

NCT Number: NCT02477982

Influence of Obesity on Propofol Pharmacokinetics During Cardiopulmonary Bypass

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.

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Key information

About this study

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 In addition, just before any rescue propofol dose administration, an unscheduled sample will be withdrawn

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Clearance (Cl/)

    Time frame: intraoperative

  2. volume of distribution of first compartment (V1)

    Time frame: intraoperative

  3. Clearance from first to second compartment (Q1)

    Time frame: intraoperative

  4. volume of distribution of second compartment (V1)

    Time frame: intraoperative

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jun 23, 2015
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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