ClinicalTrials.gov
ClinicalTrials.gov Menu

Pharmacogenetics of Propofol and Depth of Anesthesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01029379
Recruitment Status : Completed
First Posted : December 10, 2009
Last Update Posted : March 4, 2013
Sponsor:
Information provided by (Responsible Party):
Anna Oscarsson, University Hospital, Linkoeping

Brief Summary:

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 or disease
Anesthesia Propofol

Study Type : Observational
Actual Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Effect of Pharamocogenetices on Anesthesia Induction With Propofol
Study Start Date : January 2010
Actual Primary Completion Date : February 2013
Actual Study Completion Date : February 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia
Drug Information available for: Propofol
U.S. FDA Resources

Group/Cohort
200 patients,ASA 1



Primary Outcome Measures :
  1. EEG pattern in correlation to clinical anesthesia [ Time Frame: 20120101 ]
    EEG pattern in correlation to clinical anesthesia



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01029379


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Anna Oscarsson, Dr, University Hospital, Linkoeping
ClinicalTrials.gov Identifier: NCT01029379     History of Changes
Other Study ID Numbers: Progen1
First Posted: December 10, 2009    Key Record Dates
Last Update Posted: March 4, 2013
Last Verified: March 2013

Keywords provided by Anna Oscarsson, 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
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General