Clinical trial NCT01892683: Breath Monitoring of Propofol (Observational Study)
Official title: Breath Monitoring of Propofol in Patients Undergoing Anesthesia for Surgical Procedures(Observational Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia
Keywords: propofol
exhaled
monitoring
anesthesia
Lead sponsor: Ludwig-Maximilians - University of Munich
Sponsor class: OTHER
First posted: 2013-07-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exhaled Propofol
timeFrame: Continuous measurement during anesthetic procedure
Secondary outcomes:
Other outcomes:
Locations:
city: München
country: Germany
facility: Klinikum der Universität München, Campus Großhadern
state: Bayern
Study officials:
affiliation: Ludwig-Maximilians - University of Munich
name: Cyrill Hornuss, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.