Breath Monitoring of Propofol (Observational Study)

NCT01892683 | Completed

• 1 other identifier: ExhaledPropofolPK
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia

Keywords

propofol; exhaled; monitoring; anesthesia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Propofol

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

Interventions

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.

Also known as: propofol-lipuro

Propofol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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)

You may qualify if:

• scheduled for routine surgery
• age ≥ 18 years
• planned duration of intervention \> 1 hour
• written informed consent

You may not qualify if:

• propofol administration within 3 days prior to planned intervention
• pregnancy
• inability to give informed consent
• retraction of informed consent

Sponsors & Collaborators

• Ludwig-Maximilians - University of Munich: lead

Study Sites (1)

Klinikum der Universität München, Campus Großhadern

München, Bavaria, 81377, Germany

Location

Related 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. doi: 10.1097/01.anes.0000264746.01393.e0.

  PMID: 17413903 BACKGROUND

• 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.

  PMID: 22370587 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood plasma

MeSH Terms

Interventions

Anesthesia, General; Propofol

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Cyrill Hornuss, MD

  Ludwig-Maximilians - University of Munich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Cyrill Hornuss

Study Record Dates

• First Submitted: June 26, 2013
• First Posted: July 4, 2013
• Study Start: May 1, 2013
• Primary Completion: August 1, 2013
• Study Completion: August 1, 2013
• Last Updated: November 13, 2013

Record last verified: 2013-11

Locations

DE (1)