NCT01029379

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 10, 2009

Completed
22 days until next milestone

Study Start

First participant enrolled

January 1, 2010

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

March 4, 2013

Status Verified

March 1, 2013

Enrollment Period

3.1 years

First QC Date

December 9, 2009

Last Update Submit

March 1, 2013

Conditions

AnesthesiaPropofol

Keywords

propofoldepth of anesthesiapharmacogeneticsDepth of anesthesia in correlation to plasma concentrations of propofol

Outcome Measures

Primary Outcomes (1)

  • EEG pattern in correlation to clinical anesthesia

    EEG pattern in correlation to clinical anesthesia

    20120101

Study Arms (1)

200 patients,ASA 1

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesia and Intensive Care

Kalmar, Sweden

Location

Related Publications (1)

  • 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.

    PMID: 24891132DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

December 9, 2009

First Posted

December 10, 2009

Study Start

January 1, 2010

Primary Completion

February 1, 2013

Study Completion

February 1, 2013

Last Updated

March 4, 2013

Record last verified: 2013-03

Locations

SE(1)