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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pablo Sepulveda, Universidad del Desarrollo
ClinicalTrials.gov Identifier:
NCT01665079
First received: August 9, 2012
Last updated: August 14, 2012
Last verified: August 2012
  Purpose

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.


Condition Intervention Phase
Obesity
Drug: Propofol
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Propofol Effect-Site Target Controlled Infusion in the Obese: Characterization of the Time Profile of Bispectral Index Response.

Resource links provided by NLM:


Further study details as provided by Universidad del Desarrollo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

    Pharmacokinetic parameters (V1, V2, V3, CL, Q)

    Pharmacodynamic parameters (E0, Emax, C50, Gamma, t1/2Ke0, T peak )



Enrollment: 14
Study Start Date: April 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01665079

Locations
Chile
Clinica Alemana
Santiago, Chile
Sponsors and Collaborators
Universidad del Desarrollo
Investigators
Principal Investigator: Pablo O Sepúlveda, MD Clinica Alemana Universidad del Desarrollo
  More Information

No publications provided

Responsible Party: Pablo Sepulveda, Profesor Asociado Anestesiología, Universidad del Desarrollo
ClinicalTrials.gov Identifier: NCT01665079     History of Changes
Other Study ID Numbers: Propofol TCI obese
Study First Received: August 9, 2012
Last Updated: August 14, 2012
Health Authority: Chile: Institutional Review Board

Keywords provided by Universidad del Desarrollo:
anaesthetics iv
propofol
pharmacokinetics
pharmacodynamic

Additional relevant MeSH terms:
Propofol
Anesthetics
Anesthetics, General
Anesthetics, Intravenous
Central Nervous System Agents
Central Nervous System Depressants
Hypnotics and Sedatives
Pharmacologic Actions
Physiological Effects of Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on November 24, 2014