Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Exhaled Drug Monitor "Edmon"

Not Applicable

Withdrawn

• Conditions: Elective Surgical Procedures; Anesthesia, Intravenous

• Registration Number: NCT04586998
• Lead Sponsor: B. Braun Melsungen AG

Brief Summary

Edmon is the first Communauté Européenne (CE) marked medical device able to continuously measure propofol in the exhaled breath of patients under sedation or anaesthesia with propofol. Current scientific publications indicate that it makes sense from a pharmacologic point of view to measure propofol in the exhaled air.

If the present study can show the Edmon to be able to detect small differences in propofol plasma concentration it will underline the clinical value of measuring propofol in the exhaled breath. This might be an opportunity for a significant improvement in patient monitoring.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-10-13
• Study First Posted: 2020-10-14
• Study Start: 2021-04
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-31
• Last Update Posted: 2021-06-03
• Primary Completion: 2022-07
• Study Completion: 2022-07

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Propofol measurements	During elective surgical procedure lasting longer than 1 hour	To investigate the correlation between propofol concentrations in exhaled breath and blood plasma in patients undergoing elective surgical procedures under total intravenous anaesthesia.

Secondary Outcome Measures

Name	Time	Method
Identification of confounders with an impact on propofol exhaled breath concentration, e.g.among ventilatory and circulatory parameters	During elective surgical procedure lasting longer than 1 hour	To identify confounders among ventilatory and circulatory parameters by correlating the course of propofol values with courses of single parameters from vital sign monitor or anaesthetic machine (e.g. systolic blood pressure or positive end-expiratory pressure (PEEP))
Evaluation of the correlation between propofol exhaled breath concentration and EEG index values	During elective surgical procedure lasting longer than 1 hour	For that correlation EEG index values (Bispectral index (BIS) and suppression ratio) will be corrected by calculated remifentanil plasma concentration and then correlated to propofol exhaled breath concentrations