Measurement of Exhaled Propofol

NCT ID: NCT02199067

Last Updated: 2019-04-17

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

TERMINATED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-07-31

Study Completion Date

2019-04-30

Brief Summary

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Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total intravenous anaesthesia with propofol is done only by experience of the anaesthetist or according to pharmacokinetic models. In this study we want to investigate if the exhaled fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled propofol will be measured with an electrochemical sensor developed by "Drägerwerk AG \& Co. KGaA". Exhaled propofol levels will be compared with the corresponding arterial serum concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol levels with the Bispectral Index (BIS).

Detailed Description

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Conditions

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Anaesthesia With Propofol

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* ASA (American Society of Anaesthesiologists) classification I \& II
* Body-Mass-Index \< 35
* elective surgery with the necessity of an arterial catheter

Exclusion Criteria

* chronic obstructive lung disease
* bronchial asthma
* smokers with more than 5 packyears
* peripheral artery occlusive disease
* diabetes mellitus
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Erlangen-Nürnberg Medical School

OTHER

Sponsor Role lead

Responsible Party

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Tino Münster

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospital

Erlangen, Bavaria, Germany

Site Status

Countries

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Germany

References

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Schmidt S, Ihmsen H, Munster T, Schuttler J, Jeleazcov C, Wehrfritz A. Determination of the Long-Term Stability of Propofol in Human Plasma Frozen for Eight Years and Quantified by UHPLC-MS/MS. Int J Anal Chem. 2025 Aug 22;2025:7533068. doi: 10.1155/ianc/7533068. eCollection 2025.

Reference Type DERIVED
PMID: 40895257 (View on PubMed)

Other Identifiers

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PIAG1

Identifier Type: -

Identifier Source: org_study_id

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