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

NCT01596387 | Completed Phase 4 DMC

• 1 other identifier: 11-142-Fondecyt-UC-2012
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

anaesthetics iv; propofol; pharmacokinetics; pharmacodynamic

Outcome Measures

Primary Outcomes (1)

• Validated pharmacokinetic-pharmacodynamic model of Propofol in Obese patients

  During the intraoperative period and until 120 min after stopping propofol infusion

Study Arms (1)

Propofol

EXPERIMENTAL

20 obese patients(IMC\>35 kg m-2) scheduled for laparoscopic bariatric surgery.

Drug: Propofol

Interventions

Propofol DRUG

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.

Propofol

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pontificia Universidad Catolica de Chile: lead

Study Sites (1)

Hospital Clinico Pontificia Universidad Catolica

Santiago, Santiago Metropolitan, Chile

Location

Related Publications (1)

• Cortinez LI, De la Fuente N, Eleveld DJ, Oliveros A, Crovari F, Sepulveda P, Ibacache M, Solari S. Performance of propofol target-controlled infusion models in the obese: pharmacokinetic and pharmacodynamic analysis. Anesth Analg. 2014 Aug;119(2):302-310. doi: 10.1213/ANE.0000000000000317.

  PMID: 24977639 DERIVED

MeSH Terms

Conditions

Obesity

Interventions

Propofol

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Luis I Cortínez, MD

  Departamento de Anestesiología, Hospital Clínico Pontificia Universidad Católica de Chile

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor Asociado, Departamento de Anestesiología

Study Record Dates

• First Submitted: May 8, 2012
• First Posted: May 11, 2012
• Study Start: March 1, 2012
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: May 11, 2012

Record last verified: 2012-05

Locations

CL (1)