Pharmacogenetics of Propofol and Depth of Anesthesia

March 1, 2013 updated by: Anna Oscarsson, University Hospital, Linkoeping

The Effect of Pharamocogenetices on Anesthesia Induction With Propofol

Propofol, (2,6-diisopropylphenol) is a short-acting anesthetic drug used for induction and maintenance of anesthesia.

The aim of this study is to evaluate plasma concentrations of propofol in relation to depth of anesthesia, measured by continuous EEG and to correlate plasma concentrations with genetic analyses of liver enzymes responsible for drug elimination.

Our hypothesis is that there is an individual requirement of Propofol plasma concentration depending on genetic differences in drug elimination.

200 patients, ASA classification 1, planned for elective surgery of a duration of at least 30 minutes will be included in this study.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

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

  • Sweden
      • Kalmar, Sweden
        • Department of Anesthesia and Intensive Care

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

18 years to 50 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

200 patients, ASA classification 1 planned for elective surgery of at least 30 minutes duration

Description

Inclusion Criteria:

  • Healthy caucasian patents,
  • (ASAclassification 1) planned for elective surgery,
  • with body mass index 20-30,
  • free from analgetic drug > 12 hours prior to anesthesia

Exclusion Criteria:

  • Pregnancy,
  • Smoking,
  • allergy to propofol or peanuts,
  • alcohol abuse,
  • non-caucasian

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
200 patients,ASA 1

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EEG pattern in correlation to clinical anesthesia
Time Frame: 20120101
EEG pattern in correlation to clinical anesthesia
20120101

Collaborators and Investigators

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

Sponsor

University Hospital, Linkoeping

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

January 1, 2010

Primary Completion (Actual)

February 1, 2013

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

December 9, 2009

First Submitted That Met QC Criteria

December 9, 2009

First Posted (Estimate)

December 10, 2009

Study Record Updates

Last Update Posted (Estimate)

March 4, 2013

Last Update Submitted That Met QC Criteria

March 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Progen1

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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