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Clinical Trials/NCT01892683
NCT01892683
Completed
Not Applicable

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

Ludwig-Maximilians - University of Munich1 site in 1 country30 target enrollmentMay 2013

Overview

Phase
Not Applicable
Intervention
General anesthesia with propofol
Conditions
Anesthesia
Sponsor
Ludwig-Maximilians - University of Munich
Enrollment
30
Locations
1
Primary Endpoint
Exhaled Propofol
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2013
End Date
August 2013
Last Updated
12 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Cyrill Hornuss

Dr. Cyrill Hornuss

Ludwig-Maximilians - University of Munich

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

Arms & Interventions

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.

Intervention: General anesthesia with propofol

Outcomes

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.

Study Sites (1)

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