Pharmacogenetics of Propofol and Depth of Anesthesia

NCT ID: NCT01029379

Last Updated: 2013-03-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-31

Study Completion Date

2013-02-28

Brief Summary

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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

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Conditions

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Anesthesia Propofol

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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200 patients,ASA 1

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Linkoeping

OTHER

Sponsor Role lead

Responsible Party

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Anna Oscarsson

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Anesthesia and Intensive Care

Kalmar, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type DERIVED
PMID: 24891132 (View on PubMed)

Other Identifiers

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Progen1

Identifier Type: -

Identifier Source: org_study_id

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