Breath Monitoring of Propofol (Observational Study)

Completed

• Conditions: Anesthesia
• Interventions: Drug: General anesthesia with propofol

• Registration Number: NCT01892683
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2013-05
• Study First Submitted: 2013-06-26
• Study First Submitted QC: 2013-07-01
• Study First Posted: 2013-07-04
• Primary Completion: 2013-08
• Study Completion: 2013-08
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-11
• Last Update Posted: 2013-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Propofol	General anesthesia with 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.

Primary Outcome Measures

Name	Time	Method
Exhaled Propofol	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.

Trial Locations

Locations (1)

Klinikum der Universität München, Campus Großhadern; 🇩🇪 München, Bayern, Germany