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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

Tracking Information
First Submitted Date December 9, 2009
First Posted Date December 10, 2009
Last Update Posted Date March 4, 2013
Study Start Date January 2010
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 1, 2013)		 EEG pattern in correlation to clinical anesthesia [ Time Frame: 20120101 ]
EEG pattern in correlation to clinical anesthesia
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Pharmacogenetics of Propofol and Depth of Anesthesia
Official Title The Effect of Pharamocogenetices on Anesthesia Induction With Propofol
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 200 patients, ASA classification 1 planned for elective surgery of at least 30 minutes duration
Condition
  • Anesthesia
  • Propofol
Intervention Not Provided
Study Groups/Cohorts 200 patients,ASA 1
Publications * Khan MS, Zetterlund EL, Green H, Oscarsson A, Zackrisson AL, Svanborg E, Lindholm ML, Persson H, Eintrei C. Pharmacogenetics, plasma concentrations, clinical signs and EEG during propofol treatment. Basic Clin Pharmacol Toxicol. 2014 Dec;115(6):565-70. doi: 10.1111/bcpt.12277. Epub 2014 Jul 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 1, 2013)		 100
Original Estimated Enrollment
 (submitted: December 9, 2009)		 200
Actual Study Completion Date February 2013
Actual Primary Completion Date February 2013   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Sweden
Removed Location Countries  
 
Administrative Information
NCT Number NCT01029379
Other Study ID Numbers Progen1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Current Responsible Party Anna Oscarsson, University Hospital, Linkoeping
Original Responsible Party Professor Christina Eintrei, Linkoping University, Faculty of Health Sciences,
Current Study Sponsor University Hospital, Linkoeping
Original Study Sponsor Same as current
Collaborators Not Provided
Investigators Not Provided
PRS Account University Hospital, Linkoeping
Verification Date March 2013