跳至主要内容
临床试验/NCT01892683
NCT01892683已完成不适用

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

Ludwig-Maximilians - University of Munich1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2013年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
30
试验地点
1
主要终点
Exhaled Propofol

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

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

研究组 & 干预措施

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.

干预措施: General anesthesia with propofol (Drug)

结局指标

主要结局

Exhaled Propofol

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Cyrill Hornuss

Dr. Cyrill Hornuss

Ludwig-Maximilians - University of Munich

研究点 (1)

Loading locations...

相似试验