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Breath Monitoring of Propofol (Observational Study)

NCT ID: NCT01892683

Last Updated: 2013-11-13

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

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-05-31

Study Completion Date

2013-08-31

Brief Summary

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This trial investigates the relationship between concentrations of the anesthetic drug propofol in exhaled breath and blood in patients undergoing general anesthesia for elective surgery. The main goal of this study is to develop a population pharmacokinetic model for propofol in exhaled breath.

Detailed Description

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Propofol is a hypnotic drug commonly used for induction and maintenance of general anesthesia. Propofol is adiministered intravenously and has a comfortable side effect profile. Patients recover fast after propofol anesthesia and are less likely to suffer from post-operative nausea and vomiting compared to general anesthesia with inhalational anesthetics. However, titration of propofol can be challenging and patients may suffer from over- or underdosing during propofol anesthesia. Recent work has demonstrated that propofol is exhaled during anesthesia. Monitoring of propofol concentrations in breath gas during anesthesia may help to titrate propofol anesthesia more effectively. Yet, it is unclear how propofol concentrations vary among patients. This study aims to investigate this variation in a cohort of patients undergoing general anesthesia for elective surgical procedures. Propofol will be measured in breath gas continuously from the induction of anesthesia until recovery. Blood samples will be drawn from the start of anesthesia up to 24 h after the end of the anesthesia procedure and assayed for propofol blood concentrations. We will built a pharmacokinetic model from breath and blood measurements in order to describe the variability of propofol breath concentrations among study participants.

Conditions

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Anesthesia

Keywords

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propofol exhaled monitoring anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Propofol

This study will investigate patients that undergo routine anesthesia for elective surgical procedure at the hospital of the University of Munich(Klinikum der Universität München. Patients will receive intravenous anesthesia with propofol.

General anesthesia with propofol

Intervention Type DRUG

Study subjects will undergo general anesthesia with propofol according to the clinical standard protocol practiced at the hospital of the University of Munich.

Interventions

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General anesthesia with propofol

Study subjects will undergo general anesthesia with propofol according to the clinical standard protocol practiced at the hospital of the University of Munich.

Intervention Type DRUG

Other Intervention Names

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propofol-lipuro

Eligibility Criteria

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Inclusion Criteria

* scheduled for routine surgery
* age ≥ 18 years
* planned duration of intervention \> 1 hour
* written informed consent

Exclusion Criteria

* propofol administration within 3 days prior to planned intervention
* pregnancy
* inability to give informed consent
* retraction of informed consent
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role lead

Responsible Party

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Cyrill Hornuss

Dr. Cyrill Hornuss

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cyrill Hornuss, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Locations

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Klinikum der Universität München, Campus Großhadern

München, Bavaria, Germany

Site Status

Countries

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Germany

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)

Hornuss C, Wiepcke D, Praun S, Dolch ME, Apfel CC, Schelling G. Time course of expiratory propofol after bolus injection as measured by ion molecule reaction mass spectrometry. Anal Bioanal Chem. 2012 Apr;403(2):555-61. doi: 10.1007/s00216-012-5856-3. Epub 2012 Feb 28.

Reference Type BACKGROUND
PMID: 22370587 (View on PubMed)

Other Identifiers

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ExhaledPropofolPK

Identifier Type: -

Identifier Source: org_study_id