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
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
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Santiago, Chile
- Clinica Alemana
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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 |
|---|---|
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Experimental: Propofol
14 obese patients(IMC>35 kg m-2) scheduled for laparoscopic bariatric surgery
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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
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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
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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.
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
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.