Breath Gas Measurement of Propofol During Anesthesia in Patients With Endourological Procedures
Study to Estimate Central Propofol Effect by Measuring Exhaled Propofol Concentrations in Patients
1 other identifier
interventional
22
1 country
1
Brief Summary
Propofol can be measured continuously in breath gas during anesthesia. This study compares propofol concentration in plasma and breath gas and processed electroencephalographic monitoring (bispectral index) under clinical conditions with patients and total intravenous anesthesia. Target controlled infusion technique is used to deliver adequate propofol concentration in plasma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 15, 2013
CompletedFirst Posted
Study publicly available on registry
April 18, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 9, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 9, 2017
CompletedDecember 12, 2017
December 1, 2017
5.2 years
April 15, 2013
December 9, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Exhaled propofol (parts per billion)
Continuous measurement over 40 min during the induction of anesthesia and 30 min during recovery of anesthesia
Study Arms (1)
propofol
EXPERIMENTALPropofol Patients will receive propofol anesthesia on the study day
Interventions
Eligibility Criteria
You may qualify if:
- 18 years of age
- Written informed consent
- Ability and willingness to give written informed consent
- American Society of Anesthesiologists (ASA) risk score I-II
You may not qualify if:
- Denial of the patient
- Patients ASA physical status III- IV
- Pregnancy
- Volunteers with history of neurological disease or stroke
- Volunteers with a history of recreational drug abuse
- Volunteers with a history of alcohol abuse
- Known drug allergies
- History of adverse events during general anesthesia
- Total intravenous anesthesia not practicable
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Luebecklead
- Draegercollaborator
Study Sites (1)
Dept. of Anesthesiology and Intensive Care
Lübeck, Schleswig-Holstein, 23538, Germany
Related Publications (1)
Grossherr M, Hengstenberg A, Meier T, Dibbelt L, Igl BW, Ziegler A, Schmucker P, Gehring H. Propofol concentration in exhaled air and arterial plasma in mechanically ventilated patients undergoing cardiac surgery. Br J Anaesth. 2009 May;102(5):608-13. doi: 10.1093/bja/aep053. Epub 2009 Mar 31.
PMID: 19336539BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hartmut Gehring, Professor
University of Luebeck
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PhD, MD
Study Record Dates
First Submitted
April 15, 2013
First Posted
April 18, 2013
Study Start
October 1, 2012
Primary Completion
December 9, 2017
Study Completion
December 9, 2017
Last Updated
December 12, 2017
Record last verified: 2017-12