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Breath Monitoring of Propofol (Observational Study)

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ClinicalTrials.gov Identifier: NCT01892683
Recruitment Status : Completed
First Posted : July 4, 2013
Last Update Posted : November 13, 2013
Sponsor:
Information provided by (Responsible Party):
Cyrill Hornuss, Ludwig-Maximilians - University of Munich

Tracking Information
First Submitted Date June 26, 2013
First Posted Date July 4, 2013
Last Update Posted Date November 13, 2013
Study Start Date May 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 1, 2013)
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.
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01892683 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Breath Monitoring of Propofol (Observational Study)
Official Title Breath Monitoring of Propofol in Patients Undergoing Anesthesia for Surgical Procedures(Observational Study)
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Blood plasma
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)
Condition Anesthesia
Intervention Drug: General anesthesia with propofol
Study subjects will undergo general anesthesia with propofol according to the clinical standard protocol practiced at the hospital of the University of Munich.
Other Name: propofol-lipuro
Study Groups/Cohorts 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: Drug: General anesthesia with propofol
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 1, 2013)
30
Original Estimated Enrollment Same as current
Actual Study Completion Date August 2013
Actual Primary Completion Date August 2013   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01892683
Other Study ID Numbers ExhaledPropofolPK
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Cyrill Hornuss, Ludwig-Maximilians - University of Munich
Study Sponsor Ludwig-Maximilians - University of Munich
Collaborators Not Provided
Investigators
Principal Investigator: Cyrill Hornuss, MD Ludwig-Maximilians - University of Munich
PRS Account Ludwig-Maximilians - University of Munich
Verification Date November 2013