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Validation of a Pharmacokinetic Pharmacodynamic Model to Administer Propofol in Obese Patients

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ClinicalTrials.gov Identifier: NCT01596387
Recruitment Status : Completed
First Posted : May 11, 2012
Last Update Posted : May 11, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

The purpose of this study is to validate an integrated pharmacokinetic-pharmacodynamic model to administer propofol in obese patients.

Our hypothesis is that pharmacokinetic and pharmacodynamic changes occur with increasing weight and that mathematical models to administer drugs in obese patients can be developed to accurately predict dose schemes in this population.

Condition or disease Intervention/treatment Phase
Obesity Drug: Propofol Phase 4

Detailed Description:
Propofol is the most frequently used IV anesthetic today. Propofol TCI is commonly used for induction and maintenance of general anaesthesia in obese and non obese patients. However, current propofol PK models, used in TCI devices, were derived from studies that did not include obese patients. A controversial issue for propofol dose adjustment in this population has been the selection of an adequate size descriptor to scale PK parameters, as drug administration based on total body weight can result in overdose, and conversely, administration based on ideal body weight can result in a sub-therapeutic dose. In a previous study from our group, we developed a PK model capable of characterizing the influence of obesity on propofol disposition. The purpose of this study is to validate this model to administer propofol in obese patients.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Validation of a Pharmacokinetic Pharmacodynamic Model to Administer Propofol in Obese Patients
Study Start Date : March 2012
Primary Completion Date : April 2012
Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Propofol
20 obese patients(IMC>35 kg m-2) scheduled for laparoscopic bariatric surgery.
Drug: Propofol
General anesthesia will be induced administering propofol by effect site TCI system using our previously derived model, the target plasma concentration initially will be set at 4 mcg/ml. After loss of consciousness, rocuronium 0.6mg/kg, and remifentanil 0.2mcg/kg/min will be given to facilitate tracheal intubation. After intubation propofol target will be decreased to 3 for 10 minutes and then adapted to the needs of each patient to maintain stable BIS values between 40 and 50. At the end of surgery propofol infusion will be stopped, and patients will be transferred to the recovery unit extubated. Samples of 2.5 ml of arterial blood will be taken at 2, 5 and 10 min after every new target is set. Thereafter samples will be taken at 2, 5, 10, 15, 30, 60, 120 min after stopping drug infusion. Blood samples will be immediately centrifuged and then stored until analysis.

Outcome Measures

Primary Outcome Measures :
  1. Validated pharmacokinetic-pharmacodynamic model of Propofol in Obese patients [ Time Frame: During the intraoperative period and until 120 min after stopping propofol infusion ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • IMC > 35 kg m-2
  • Scheduled for laparoscopic bariatric surgery
  • ASA I-II patients
  • Between 18 and 60 yr of age.

Exclusion Criteria:

  • Patients with allergy to study drugs
  • Uncontrolled hypertension
  • Heart block greater than first degree
  • Take any drug acting in the central nervous system within 24 hrs before surgery.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01596387

Hospital Clinico Pontificia Universidad Catolica
Santiago, Region Metropolitana, Chile
Sponsors and Collaborators
Pontificia Universidad Catolica de Chile
Principal Investigator: Luis I Cortínez, MD Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ignacio Cortínez F., Profesor Asociado, Departamento de Anestesiología, Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier: NCT01596387     History of Changes
Other Study ID Numbers: 11-142-Fondecyt-UC-2012
First Posted: May 11, 2012    Key Record Dates
Last Update Posted: May 11, 2012
Last Verified: May 2012

Keywords provided by Ignacio Cortínez F., Pontificia Universidad Catolica de Chile:
anaesthetics iv

Additional relevant MeSH terms:
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anesthetics, Intravenous
Anesthetics, General