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

Population PK/PD of propofol and nadroparin in extreme morbidly obese patients - POP4 study

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON36134
Enrollment
8
Registered
2011-09-09
Start date
2012-02-20
Completion date
Unknown
Last updated
2024-05-06

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

Conditions

Obesitas pharmacokinetics and pharmacodynamics of propofol and nadroparin in morbidly obese patients

Interventions

None listed

Sponsors

Sint Antonius Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
Pharmacokinetic parameters of propofol in patients with a total body weight higher than 170 kg: clearance, intercompartmental clearance, volume of central compartment and volume of peripheral compartment. Pharmacodynamic parameters of nadroparin using anti-Xa levels in patients with a total body weight higher than 170 kg: clearance, intercompartmental clearance, volume of central compartment and volume of peripheral compartment, absorption rate constant, transit rate constant.

Secondary

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

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)