NCT03943745

Brief Summary

PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

October 25, 2018

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

May 7, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 9, 2019

Completed
4.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2024

Completed
Last Updated

May 5, 2026

Status Verified

December 1, 2024

Enrollment Period

5.4 years

First QC Date

May 7, 2019

Last Update Submit

April 28, 2026

Conditions

Keywords

EEGPropofol

Outcome Measures

Primary Outcomes (1)

  • EEG slow-wave activity

    EEG slow-wave activity is defined by the low-frequency (\<1 Hz) signal power. The study investigates the topographic distribution of the activity as well as the coupling of the activity between the electrodes. The relation of slow-wave activity and loss of consciousness will be investigated as well.

    Induction of anesthesia (approx. 10-30 min)

Secondary Outcomes (1)

  • EEG activity on other frequency bands

    Induction of anesthesia (approx. 10-30 min)

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Neurologically healthy individuals coming to hospital for elective surgery with general anesthesia

You may qualify if:

  • ASA 1-2 (no neurological or cardiovascular diseases)

You may not qualify if:

  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Karelia Central Hospital

Lappeenranta, 53130, Finland

Location

Related Publications (3)

  • Kortelainen J, Vayrynen E, Huuskonen U, Laurila J, Koskenkari J, Backman JT, Alahuhta S, Seppanen T, Ala-Kokko T. Pilot Study of Propofol-induced Slow Waves as a Pharmacologic Test for Brain Dysfunction after Brain Injury. Anesthesiology. 2017 Jan;126(1):94-103. doi: 10.1097/ALN.0000000000001385.

    PMID: 27749312BACKGROUND
  • Kortelainen J, Vayrynen E, Juuso I, Laurila J, Koskenkari J, Ala-Kokko T. Forehead electrodes sufficiently detect propofol-induced slow waves for the assessment of brain function after cardiac arrest. J Clin Monit Comput. 2020 Feb;34(1):105-110. doi: 10.1007/s10877-019-00282-3. Epub 2019 Feb 20.

    PMID: 30788811BACKGROUND
  • Kortelainen J, Ala-Kokko T, Tiainen M, Strbian D, Rantanen K, Laurila J, Koskenkari J, Kallio M, Toppila J, Vayrynen E, Skrifvars MB, Hastbacka J. Early recovery of frontal EEG slow wave activity during propofol sedation predicts outcome after cardiac arrest. Resuscitation. 2021 Aug;165:170-176. doi: 10.1016/j.resuscitation.2021.05.032. Epub 2021 Jun 7.

    PMID: 34111496BACKGROUND

Study Officials

  • Jukka Kortelainen, MD, PhD

    University of Oulu

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 7, 2019

First Posted

May 9, 2019

Study Start

October 25, 2018

Primary Completion

March 28, 2024

Study Completion

March 28, 2024

Last Updated

May 5, 2026

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations