Breath Monitoring of Propofol (Observational Study)

Ludwig Maximilian University of Munich

Status: Completed

Conditions: Anesthesia

Treatments: Drug: General anesthesia with propofol

Study type: Observational

Funder types: Other

Identifiers

NCT01892683

ExhaledPropofolPK

Details and patient eligibility

About

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.

Full 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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

30 participants in 1 patient group

Propofol

Description:

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.

Treatment:

Drug: General anesthesia with propofol