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

August 14, 2012 updated by: Pablo Sepulveda, Universidad del Desarrollo

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Chile
      • Santiago, Chile
        • Clinica Alemana

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol
14 obese patients(IMC>35 kg m-2) scheduled for laparoscopic bariatric surgery
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Profile of Pharmacokinetic and Pharmacodynamic of an induction bolus dose of propofol in obese patients.
Time Frame: 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 )
1, 2, 3, 5, 7 and 10 minutes after the initial bolus dose or until BIS > 75

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidad del Desarrollo

Investigators

  • Principal Investigator: Pablo O Sepulveda, MD, Clinica Alemana Universidad del Desarrollo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

November 1, 2011

Study Completion (Actual)

November 1, 2011

Study Registration Dates

First Submitted

August 9, 2012

First Submitted That Met QC Criteria

August 14, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

August 15, 2012

Last Update Submitted That Met QC Criteria

August 14, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Propofol TCI obese

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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