NCT04771702

Brief Summary

Edmon (BBraun, Germany) is a portable, commercially available device for measurement of propofol in exhaled air. The study will aim at evaluating the sensitivity and specificity of such exhaled propofol values compared with plasma propofol and measures of anaesthetic and antinociceptive effect.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 13, 2021

Completed
1 day until next milestone

Study Start

First participant enrolled

January 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 25, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
Last Updated

February 25, 2021

Status Verified

February 1, 2021

Enrollment Period

1.4 years

First QC Date

January 13, 2021

Last Update Submit

February 23, 2021

Conditions

Anesthesia

Outcome Measures

Primary Outcomes (1)

  • Exhaled air versus plasma concentration

    per-operative

Secondary Outcomes (3)

  • EEG recording

    per-operative

  • Exhaled propofol 2

    per-operative

  • Nociceptive stimulation

    per-operative

Study Arms (1)

Edmon arm

EXPERIMENTAL
Device: Edmon

Interventions

EdmonDEVICE

Exhaled air will be analyzed for propofol

Edmon arm

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective patients scheduled for low-back surgery
  • BMI between 20 -32 kg/m2
  • ASA I-II
  • Written informed concent

You may not qualify if:

  • Contraindication to propofol TCI
  • Use of psychopharmaco or neurologic disease
  • Pregnancy or breast feeding

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dept of Anesthesiology, Oslo University Hospital, Ullevaal

Oslo, 0407, Norway

RECRUITING

Study Officials

  • Kristin S Thagaard, MD

    Oslo University Hospital

    STUDY DIRECTOR

Central Study Contacts

Johan Raeder, PhD

CONTACT

004792249669johan.rader@medisin.uio.no

Torsten Eken, PhD

CONTACT

004795079939torsten.eken@medisin.uio.no

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The intervention is to have patients in 20 min stable anaesthesia before start of surgery in order to validate the use of exhaled propofol versus pharmakokinetic modelling and measured plasma concentration
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 13, 2021

First Posted

February 25, 2021

Study Start

January 14, 2021

Primary Completion

June 1, 2022

Study Completion

December 1, 2024

Last Updated

February 25, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)