Measurement of Exhaled Propofol

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02199067

Acronym

PIAG1

Enrollment

Registered

2014-07-24

Start date

2014-07-31

Completion date

2019-04-30

Last updated

2019-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anaesthesia With Propofol

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).

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results