NCT04586998

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

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: B. Braun Melsungen AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Elective Surgical Procedures
• Anesthesia, Intravenous

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-04-01
• Primary completion: 2022-07-01
• Completion: 2022-07-01
• First posted: 2020-10-14
• Last updated: 2021-06-03