Population PK/PD of propofol and nadroparin in extreme morbidly obese patients

Completed

Conditions: Obesitas
10017998
pharmacokinetics and pharmacodynamics of propofol and nadroparin in morbidly obese patients

Registration Number: NL-OMON36134

Lead Sponsor: Sint Antonius Ziekenhuis

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 8

Inclusion Criteria

8 morbidly obese patients a total body weight higher than 170 kg undergoing laparoscopic banding, laparoscopic sleeve gastrectomy or gastric bypass surgery, with a Body Mass Index > 40 kg/m2, 18-60 year old and American Society of Anaesthesiologists (ASA) physical status II to III.

Exclusion Criteria

Epilepsy, pregnancy, breastfeeding and known allergy for propofol, nadroparin, egg lecithin or soy bean oil.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Pharmacokinetic parameters of propofol in patients with a total body weight<br /><br>higher than 170 kg: clearance, intercompartmental clearance, volume of central<br /><br>compartment and volume of peripheral compartment.<br /><br>Pharmacodynamic parameters of nadroparin using anti-Xa levels in patients with<br /><br>a total body weight higher than 170 kg: clearance, intercompartmental<br /><br>clearance, volume of central compartment and volume of peripheral compartment,<br /><br>absorption rate constant, transit rate constant. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Pharmacodynamic parameters of propofol in patients with a total body weight<br /><br>higher than 170 kg; time to induction of anaesthesia (stop counting, eyelash<br /><br>reflex, quality of anaesthesia, corresponding dose required for induction of<br /><br>anaesthesia for both induction doses), EC50 using BIS, required doses of<br /><br>propofol during maintenance of anaesthesia, wake-up time.<br /><br>The occurrence of bleedings or thrombotic events in patients with a total body<br /><br>weight higher than 170 kg.<br /><br>Cardiac output records during surgery, measured by the NICOM® (Cheetah Medical)<br /><br>and Vigileo (Edwards Lifesciences) monitor </p><br>