Population PK/PD of Propofol in the Morbidly Obese Patient

This study has been completed.
Sponsor:
Information provided by:
St. Antonius Hospital
ClinicalTrials.gov Identifier:
NCT00395681
First received: November 1, 2006
Last updated: October 21, 2010
Last verified: November 2006
  Purpose

Rationale: The extreme increase of obesity in the last years had led to this study. There is no consensus about how to anaesthetise morbidly obese patients. The amounts of narcotics given vary widely and rather depend on the anaesthetist than on the pharmacokinetics and dynamics in the morbidly obese patient. Reason for this is that it is not clear in what extend the pharmacokinetics and dynamics are affected in the morbidly obese patient.

Objective: The study is performed in order to develop a population pharmacokinetic and pharmacodynamic model of Propofol when used for induction and maintenance of anaesthesia in the morbidly obese patient (BMI > 40). A covariate analysis will be performed in order to account for variability in pharmacokinetic and/or pharmacodynamic parameters. This model will take into account patient and procedure bound covariates. The results will be used to develop individualised dosing schemes of Propofol when used for induction and maintenance of anaesthesia in morbidly obese patients.

Study design: A randomised, therapeutic and non-invasive study.

Study population: Morbidly obese patients with a Body Mass Index > 40 undergoing laparoscopic banding or gastric bypass surgery, 18-60 year old.

Intervention (if applicable): Patients will be randomised into two groups, one group will be given 200 milligrams of Propofol and the other group will be given 350 milligrams of Propofol. During the induction of anaesthesia with Propofol over 60 seconds, the patient is asked to count in order to measure time to induction of anaesthesia. During and following anaesthesia a maximum of 50 ml of blood will be taken from an indwelling arterial line. Depth of sedation will be measured using non-invasive Bispectral Index (target 40-60) and other standard measures (heart frequency and blood pressure).

Main study parameters/endpoints: Primary endpoints: pharmacokinetic parameters; clearance, intercompartmental clearance, volume of central compartment and volume of peripheral compartment.

Secondary endpoints: pharmacodynamic parameters; 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.

Nature and extent of the burden and risks associated with participation benefit and group relatedness: A maximum amount of 50 milliliters of blood will be sampled from an indwelling arterial line. The patient will be asked to count slowly during induction of anaesthesia. Both induction doses of 200 and 350 milligrams are currently used standard induction doses for morbidly obese patients.


Condition Intervention Phase
Morbid Obesity
Drug: Diprivan
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver)
Primary Purpose: Treatment
Official Title: Population Pharmacokinetics and Pharmacodynamics of Propofol in the Morbidly Obese Patient

Resource links provided by NLM:


Further study details as provided by St. Antonius Hospital:

Enrollment: 20
Study Start Date: September 2007
Study Completion Date: September 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: propofol
propofol 200 mg versus 350 mg
Drug: Diprivan
Propofol 200 mg versus 350 mg
Active Comparator: Propofol
Propofol 350 mg versus 200 mg
Drug: Diprivan
Propofol 200 mg versus 350 mg

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients with a Body Mass Index > 40 undergoing laparoscopic banding or gastric bypass surgery.

Exclusion Criteria:

  • Epilepsy, pregnancy, breastfeeding and known allergy for Propofol, egg lecithin or soy bean oil.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00395681

Locations
Netherlands
st. Antonius hospital
Nieuwegein, Netherlands
Sponsors and Collaborators
St. Antonius Hospital
Investigators
Principal Investigator: Simone van Kralingen, resident St. Antonius Ziekenhuis
  More Information

No publications provided by St. Antonius Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: S. van Kralingen, St. Antonius Hospital
ClinicalTrials.gov Identifier: NCT00395681     History of Changes
Other Study ID Numbers: 13980
Study First Received: November 1, 2006
Last Updated: October 21, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by St. Antonius Hospital:
Obesity
Propofol
Morbidly obese
BMI

Additional relevant MeSH terms:
Obesity
Obesity, Morbid
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Propofol
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on July 24, 2014