Pharmacogenetics of Propofol and Depth of Anesthesia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Anna Oscarsson, University Hospital, Linkoeping
ClinicalTrials.gov Identifier:
NCT01029379
First received: December 9, 2009
Last updated: March 1, 2013
Last verified: March 2013
  Purpose

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.


Condition
Anesthesia
Propofol

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Pharamocogenetices on Anesthesia Induction With Propofol

Resource links provided by NLM:


Further study details as provided by University Hospital, Linkoeping:

Primary Outcome Measures:
  • EEG pattern in correlation to clinical anesthesia [ Time Frame: 20120101 ] [ Designated as safety issue: No ]
    EEG pattern in correlation to clinical anesthesia


Enrollment: 100
Study Start Date: January 2010
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
200 patients,ASA 1

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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
  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: NCT01029379

Locations
Sweden
Department of Anesthesia and Intensive Care
Kalmar, Sweden
Sponsors and Collaborators
University Hospital, Linkoeping
  More Information

No publications provided

Responsible Party: Anna Oscarsson, Dr, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01029379     History of Changes
Other Study ID Numbers: Progen1
Study First Received: December 9, 2009
Last Updated: March 1, 2013
Health Authority: Sweden: Medical Products Agency

Keywords provided by University Hospital, Linkoeping:
propofol
depth of anesthesia
pharmacogenetics
Depth of anesthesia in correlation to plasma concentrations of propofol

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

ClinicalTrials.gov processed this record on August 27, 2014