Monitoring Exhaled Propofol to Individualize General Anesthesia

NCT ID: NCT01191021

Last Updated: 2013-06-05

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

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2010-10-31

Brief Summary

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This trial investigates the relationship between concentrations of the anesthetic drug propofol in exhaled breath, blood and drug effect in volunteers undergoing general anesthesia. The main goal of this study is to develop a pharmacokinetic - and dynamic model for propofol in exhaled breath.

Detailed Description

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Conditions

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General Anesthesia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol

Volunteers will receive propofol anesthesia on the study day.

Group Type OTHER

Propofol Anesthesia

Intervention Type DRUG

Volunteers will undergo propofol anesthesia for 90 min.

Interventions

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Propofol Anesthesia

Volunteers will undergo propofol anesthesia for 90 min.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* 18 years of age

* Written informed consent
* Ability and willingness to give written informed consent
* American Society of Anesthesiologists (ASA) risk score I

Exclusion Criteria

* Volunteers ASA physical status II - III
* Pregnancy
* Volunteers with history of neurological disease or stroke
* Volunteers with a history of recreational drug abuse
* Volunteers with a history of alcohol abuse
* Smokers
* Anesthesia within 6 months
* Known drug allergies
* History of adverse events during general anesthesia
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Christian C Apfel, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco

Cyrill Hornuss, MD

Role: PRINCIPAL_INVESTIGATOR

Perioperative Clinical Research Core, Department of Anesthesia, University of California San Francisco

Locations

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Department of Anesthesia and Perioperative Care, UCSF

San Francisco, California, United States

Site Status

Countries

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United States

References

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Hornuss C, Praun S, Villinger J, Dornauer A, Moehnle P, Dolch M, Weninger E, Chouker A, Feil C, Briegel J, Thiel M, Schelling G. Real-time monitoring of propofol in expired air in humans undergoing total intravenous anesthesia. Anesthesiology. 2007 Apr;106(4):665-74. doi: 10.1097/01.anes.0000264746.01393.e0.

Reference Type BACKGROUND
PMID: 17413903 (View on PubMed)

Other Identifiers

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H54427-35579

Identifier Type: -

Identifier Source: org_study_id

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