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

B. Braun Melsungen AG

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Conditions

Elective Surgical Procedures Anesthesia, Intravenous

Interventions

Exhaled drug monitor "Edmon"DEVICE

Taking samples of exhaled breath every minute during elective surgery in comparison to blood samples taken at predefined time points.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

* 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

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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