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

B. Braun

Status: Withdrawn

Conditions: Elective Surgical Procedures; Anesthesia, Intravenous

Treatments: Device: Exhaled drug monitor "Edmon"

Study type: Interventional

Funder types: Industry

Identifiers

NCT04586998

HC-G-H-1716

Details and patient eligibility

About

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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Exhaled drug monitor "Edmon"

Experimental group

Description:

Comparison between propofol in exhaled breath and blood plasma

Treatment:

Device: Exhaled drug monitor "Edmon"