Measurement of Exhaled Propofol

Terminated

• Conditions: Anaesthesia With Propofol

• Registration Number: NCT02199067
• Lead Sponsor: University of Erlangen-Nürnberg Medical School

Brief Summary

Propofol is a common intravenous anaesthetic drug used for anaesthesia induction and for permanent infusion to maintain anaesthesia (total intravenous anaesthesia). Different to the volatile anaesthetics (feedback concentrations in exhaled breathing gas) piloting of an total intravenous anaesthesia with propofol is done only by experience of the anaesthetist or according to pharmacokinetic models. In this study we want to investigate if the exhaled fraction of propofol is a potential measurement parameter for piloting anaesthesia. Exhaled propofol will be measured with an electrochemical sensor developed by "Drägerwerk AG \& Co. KGaA". Exhaled propofol levels will be compared with the corresponding arterial serum concentrations of propofol. Furthermore we investigate the correlation of exhaled propofol levels with the Bispectral Index (BIS).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-23
• Study First Posted: 2014-07-24
• Primary Completion: 2018-12
• Status Verified: 2019-04
• Study Completion: 2019-04
• Last Update Submitted: 2019-04-16
• Last Update Posted: 2019-04-17

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• ASA (American Society of Anaesthesiologists) classification I & II
• Body-Mass-Index < 35
• elective surgery with the necessity of an arterial catheter

Exclusion Criteria

• chronic obstructive lung disease
• bronchial asthma
• smokers with more than 5 packyears
• peripheral artery occlusive disease
• diabetes mellitus

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
exhaled propofol levels in breathing gas	continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)

Secondary Outcome Measures

Name	Time	Method
Bispectral Index (BIS)	continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)
propofol concentration in arterial blood serum	samples taken during anaesthesia (13 blood samples), duration of anaesthesia depends on surgery, 2 to 12 hours

Trial Locations

Locations (1)

University Hospital; 🇩🇪 Erlangen, Bavaria, Germany