Clinical trial NCT04586998: Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Exhaled Drug Monitor "Edmon"
Official title: Prospective Multicenter Open-Label Single Group Study on the Comparison Between Propofol Concentration in Exhaled Breath and Blood Plasma Using the Propofol Monitor Edmon in Patients Undergoing Elective Surgery Under Total Intravenous Anaesthesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Elective Surgical Procedures
Anesthesia, Intravenous
Keywords: EDMON
Propofol detection
Exhaled breath
Drug monitoring
Lead sponsor: B. Braun Melsungen AG
Sponsor class: INDUSTRY
First posted: 2020-10-14
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.


Eligibility 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

Primary outcomes:
measure: Propofol measurements
timeFrame: During elective surgical procedure lasting longer than 1 hour
Secondary outcomes:
measure: Identification of confounders with an impact on propofol exhaled breath concentration, e.g.among ventilatory and circulatory parameters
timeFrame: During elective surgical procedure lasting longer than 1 hour
measure: Evaluation of the correlation between propofol exhaled breath concentration and EEG index values
timeFrame: During elective surgical procedure lasting longer than 1 hour
Other outcomes:
Locations:
Study officials:
affiliation: Universitaetsklinikum des Saarlandes
name: Thomas Volk, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: