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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01596387
• Other study ID #: 11-142-Fondecyt-UC-2012
• Status: Completed
• Phase: Phase 4
• First received: May 8, 2012
• Last updated: May 10, 2012
• Start date: March 2012
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Pontificia Universidad Catolica de Chile
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

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.

Study Design

Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Obesity

Intervention

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.

Locations

Country	Name	City	State
Chile	Hospital Clinico Pontificia Universidad Catolica	Santiago	Region Metropolitana

Sponsors (1)

Lead Sponsor	Collaborator
Pontificia Universidad Catolica de Chile

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validated pharmacokinetic-pharmacodynamic model of Propofol in Obese patients		During the intraoperative period and until 120 min after stopping propofol infusion	No