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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665079
• Other study ID #: Propofol TCI obese
• Status: Completed
• Phase: Phase 4
• First received: August 9, 2012
• Last updated: August 14, 2012
• Start date: April 2011
• Est. completion date: November 2011

Study information

• Verified date: August 2012
• Source: Universidad del Desarrollo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

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
Propofol was administered by plasma TCI and a bolus dose was given by setting the initial plasma target between 12-16 µg/ml according to the anesthesiologist criteria. The protocol target range was selected based on previous experience using this model in the obese. After the patients reached this target, propofol infusion was stopped until the patients woke up (BIS>75). No other drugs were given during this period. Facemask ventilation was assisted only if necessary to maintain SpO2 > 90%. BIS data and propofol infusion data were automatically recorded every five seconds using the AnestFusor© program. Arterial blood samples of 4 ml for propofol assays were collected at 1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75. After the patient woke up the study was considered finished and propofol infusion was restarted according to the anesthesiologist plan.

Locations

Country	Name	City	State
Chile	Clinica Alemana	Santiago

Sponsors (1)

Lead Sponsor	Collaborator
Universidad del Desarrollo

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.	Pharmacokinetic parameters (V1, V2, V3, CL, Q); Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )	1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75	No