Measurement of Exhaled Propofol

Anaesthesia With Propofol Clinical Trial

— PIAG1  

Official title:

Measurement of Exhaled Propofol During a Total Intravenous Anesthesia With Propofol and Remifentanil

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02199067
• Other study ID #: PIAG1
• Status: Terminated
• Start date: July 2014
• Est. completion date: April 2019

Study information

• Verified date: April 2019
• Source: University of Erlangen-Nürnberg Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: April 2019
• Est. primary completion date: December 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Anaesthesia With Propofol

Locations

Country	Name	City	State
Germany	University Hospital	Erlangen	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	exhaled propofol levels in breathing gas		continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)
Secondary	propofol concentration in arterial blood serum		samples taken during anaesthesia (13 blood samples), duration of anaesthesia depends on surgery, 2 to 12 hours
Secondary	Bispectral Index (BIS)		continous recording during the whole anaesthesia (duration depents on surgery, between 2 and 12 hours)