Breath Monitoring of Propofol (Observational Study)

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01892683
• Other study ID #: ExhaledPropofolPK
• Status: Completed
• Phase: N/A
• First received: June 26, 2013
• Last updated: November 11, 2013
• Start date: May 2013
• Est. completion date: August 2013

Study information

• Verified date: November 2013
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 2013
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Anesthesia

Intervention

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.

Locations

Country	Name	City	State
Germany	Klinikum der Universität München, Campus Großhadern	München	Bayern

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exhaled Propofol	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.	Continuous measurement during anesthetic procedure	No