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

NCT04586998 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2021-06-03

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • B. Braun Melsungen AG

    lead INDUSTRY

Principal Investigators

  • Thomas Volk, Prof. Dr. · Universitaetsklinikum des Saarlandes

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-04-30
Primary Completion
2022-07-31
Completion
2022-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04586998 on ClinicalTrials.gov