Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response

Phase 4

Completed

• Conditions: Obesity
• Interventions: Drug: Propofol

• Registration Number: NCT01665079
• Lead Sponsor: Universidad del Desarrollo

Brief Summary

The aim of this study is to characterize the Pharmacokinetic/Pharmacodynamic relationship of a single bolus dose of propofol in obese patients and to extract a time to peak effect (t-peak) from the estimated model parameters.

Detailed Description

Target controlled infusion (TCI) is a technique to administer intravenous drugs that allows rapid achievement and maintenance of predetermined drug concentrations, either in plasma (Cp) or at the site of effect (Ce).

To characterize the time profile of propofol effect an additional parameter, the equilibration half time between plasma and effect site (T1/2keo) needs to be incorporated in the pharmacokinetic (PK) model.

Study Timeline

• Study Start: 2011-04
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-08
• Study First Submitted: 2012-08-09
• Study First Submitted QC: 2012-08-14
• Last Update Submitted: 2012-08-14
• Study First Posted: 2012-08-15
• Last Update Posted: 2012-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

Inclusion Criteria

• IMC > 35 kg m-2
• Scheduled for laparoscopic bariatric surgery
• ASA I-II patients
• Between 20 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Propofol	Propofol	14 obese patients(IMC\>35 kg m-2) scheduled for laparoscopic bariatric surgery

Primary Outcome Measures

Name	Time	Method
Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.	1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75	Pharmacokinetic parameters (V1, V2, V3, CL, Q); Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )

Trial Locations

Locations (1)

Clinica Alemana; 🇨🇱 Santiago, Chile