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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ignacio Cortínez F., Pontificia Universidad Catolica de Chile
ClinicalTrials.gov Identifier:
NCT01596387
First received: May 8, 2012
Last updated: May 10, 2012
Last verified: May 2012
  Purpose

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 Intervention Phase
Obesity
Drug: Propofol
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Validation of a Pharmacokinetic Pharmacodynamic Model to Administer Propofol in Obese Patients

Resource links provided by NLM:


Further study details as provided by Pontificia Universidad Catolica de Chile:

Primary Outcome Measures:
  • Validated pharmacokinetic-pharmacodynamic model of Propofol in Obese patients [ Time Frame: During the intraoperative period and until 120 min after stopping propofol infusion ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: March 2012
Study Completion Date: May 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

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

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01596387

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

No publications provided by Pontificia Universidad Catolica de Chile

Additional 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
Study First Received: May 8, 2012
Last Updated: May 10, 2012
Health Authority: Chile: Institutional Review Board

Keywords provided by Pontificia Universidad Catolica de Chile:
anaesthetics iv
propofol
pharmacokinetics
pharmacodynamic

Additional relevant MeSH terms:
Propofol
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 25, 2014