Pharmacogenetics of Propofol and Depth of Anesthesia

Anesthesia Clinical Trial

Official title:

The Effect of Pharamocogenetices on Anesthesia Induction With Propofol

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01029379
• Other study ID #: Progen1
• Status: Completed
• Phase: N/A
• First received: December 9, 2009
• Last updated: March 1, 2013
• Start date: January 2010
• Est. completion date: February 2013

Study information

• Verified date: March 2013
• Source: University Hospital, Linkoeping
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Medical Products Agency
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia
• Propofol

Locations

Country	Name	City	State
Sweden	Department of Anesthesia and Intensive Care	Kalmar

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	EEG pattern in correlation to clinical anesthesia	EEG pattern in correlation to clinical anesthesia	20120101	No