Anesthesia, Intravenous, Elective Surgical Procedures
Conditions
Keywords
EDMON, Propofol detection, Exhaled breath, Drug monitoring
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.
Interventions
DEVICEExhaled drug monitor Edmon
Taking samples of exhaled breath every minute during elective surgery in comparison to blood samples taken at predefined time points.
Sponsors
B. Braun Melsungen AG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Inclusion criteria * Male or female patients undergoing elective surgical procedures * Expected duration of the surgical procedure \> 1h * General anaesthesia (TIVA) with propofol and remifentanil under orotracheal intubation * Medical need for an arterial line for an invasive haemodynamic monitoring during anaesthesia * Written informed consent * Age ≥ 18 years * ASA I-III * BMI \< 35 kg/m² * Women of child bearing potential: negative pregnancy test * BIS monitoring feasible (e.g. no surgical procedures on the frontal brain) * The patient is expected to be extubated in the OR after end of surgery *
Exclusion criteria
* Patients with contraindications for propofol, remifentanil or for the planned anaesthetic procedure * Cardiac surgery * Lung surgery * Organ transplant procedures * Pulmonary diffusion anomalies (e.g. pulmonary fibrosis), known from medical history * Patients on renal replacement therapy * Participation in another interventional trial * Breastfeeding women * Unilateral lung ventilation * Emergency surgery * Patient is not able to give his/her written informed consent * Patients with a haemoglobin level below 10 g/dl
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Outcome results
None listed