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Breath Monitoring of Propofol (Observational Study)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01892683
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : November 13, 2013
Information provided by (Responsible Party):
Cyrill Hornuss, Ludwig-Maximilians - University of Munich

Brief Summary:
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.

Condition or disease Intervention/treatment
Anesthesia Drug: General anesthesia with propofol

Detailed Description:
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.

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Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Breath Monitoring of Propofol in Patients Undergoing Anesthesia for Surgical Procedures(Observational Study)
Study Start Date : May 2013
Actual Primary Completion Date : August 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Propofol

Group/Cohort Intervention/treatment
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.
Drug: 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.
Other Name: propofol-lipuro

Primary Outcome Measures :
  1. Exhaled Propofol [ Time Frame: Continuous measurement during anesthetic procedure ]
    Propofol concentrations in breath gas will be assessed every 500 ms during the anesthesia procedure. Participants will be followed for the duration of the anesthesia procedure, an expected average of 4 hours.

Biospecimen Retention:   Samples Without DNA
Blood plasma

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Study persons undergo general anesthesia for elective routine surgery at the hospital of the University of Munich (Klinikum der Universität München)

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01892683

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Klinikum der Universität München, Campus Großhadern
München, Bayern, Germany, 81377
Sponsors and Collaborators
Ludwig-Maximilians - University of Munich
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Principal Investigator: Cyrill Hornuss, MD Ludwig-Maximilians - University of Munich

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Responsible Party: Cyrill Hornuss, Dr. Cyrill Hornuss, Ludwig-Maximilians - University of Munich Identifier: NCT01892683    
Other Study ID Numbers: ExhaledPropofolPK
First Posted: July 4, 2013    Key Record Dates
Last Update Posted: November 13, 2013
Last Verified: November 2013
Keywords provided by Cyrill Hornuss, Ludwig-Maximilians - University of Munich:
Additional relevant MeSH terms:
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Central Nervous System Depressants
Physiological Effects of Drugs
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General