An interventional study of Exhaled drug monitor "Edmon" in Elective Surgical Procedures and Anesthesia, Intravenous, sponsored by B. Braun Melsungen AG. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-06-03.
Sponsored by B. Braun Melsungen AG · Not applicable, Interventional, and Other
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.
B. Braun Melsungen AG is the lead sponsor of 46 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Male or female patients undergoing elective surgical procedures
Patients with contraindications for propofol, remifentanil or for the planned anaesthetic procedure
Comparison between propofol in exhaled breath and blood plasma
Device: Exhaled drug monitor "Edmon"
Taking samples of exhaled breath every minute during elective surgery in comparison to blood samples taken at predefined time points.
Propofol measurements
To investigate the correlation between propofol concentrations in exhaled breath and blood plasma in patients undergoing elective surgical procedures under total intravenous anaesthesia.
Time frame: During elective surgical procedure lasting longer than 1 hour
Identification of confounders with an impact on propofol exhaled breath concentration, e.g.among ventilatory and circulatory parameters
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))
Time frame: During elective surgical procedure lasting longer than 1 hour
Evaluation of the correlation between propofol exhaled breath concentration and EEG index values
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
Time frame: During elective surgical procedure lasting longer than 1 hour
No study locations are listed for this record.
This study is withdrawn, as verified in May 2021. You cannot join it, but the record below documents what was studied.
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B. Braun Melsungen AG