Breath Monitoring of Propofol (Observational Study)

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.

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Key information

Conditions

Anesthesia

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum der Universität München, Campus Großhadern

München, Bavaria, 81377, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

General anesthesia with propofol

Drug

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

Other names: propofol-lipuro

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Registry information

Official study title

Breath Monitoring of Propofol in Patients Undergoing Anesthesia for Surgical Procedures(Observational Study)

Important dates

Study start: 2013
Primary completion: 2013
Study completion: 2013
First posted: Jul 4, 2013
Registry last updated: Nov 13, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed