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CompletedNCT03943745PropoStatusUpdated May 5, 2026

EEG Changes During Induction of Propofol Anesthesia

An observational study in Anesthesia, General and Healthy Subjects, sponsored by University of Oulu. Completed at 1 site in Finland. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-05-05.

Sponsored by University of Oulu · Observational

Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
45
Ages
18 Years to 80 Years
Sex
All
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Study summary

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

Read the detailed description

PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol. EEG changes are investigated in different levels of anesthesia from awake state to deep anesthesia in which burst suppression pattern (BSP) is seen in the EEG. Furthermore, the relation of EEG changes and clinically evaluated depth of anesthesia is studied.

The study population is comprised of neurologically healthy individuals who come to the hospital for elective surgery requiring general anesthesia. The patients will not receive any pre-medication. They will give a written consent to participate to the study. During induction of anesthesia, the vital signs will be monitored using the standard protocol of the operating room. EEG will be recorded using a wireless measurement device. The EEG is observed during the recording from a laptop or tablet computer. The anesthesia is induced using propofol with a fixed infusion rate of 30 mg/kg/h. The patient is asked to squeeze the anesthetist's hand repeatedly every 10 s. The moment at which the patients does not respond to the command anymore is considered as the loss of consciousness. The infusion is continued until BSP is observed in the EEG. The infusion is then continued for 3 min after which the recording of EEG is stopped. The administration of anesthesia is then continued as required by the operation.

The EEG recording will be carried out using two different devices. The first dataset, including 20 patients, will be collected using Bittium BrainStatus EEG electrode and device. The second dataset, including 30 patients, will be collected using Nihon Kohden CerebAir device.

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Conditions studied

  • Anesthesia, General
  • Healthy Subjects

Keywords

  • EEG
  • Propofol
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In context

Lead sponsor

University of Oulu is the lead sponsor of 138 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria

  • BMI > 30
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Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
45 participants (actual)
Patient registry
No
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What researchers measure

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.

    Time frame: Induction of anesthesia (approx. 10-30 min)

Secondary outcomes

  1. EEG activity on other frequency bands

    In addition to slow wave activity, the study investigates the topographic distribution of the activities on other frequency bands (delta, theta, alpha, beta) as well as the coupling of these activities between the electrodes.The relation of these other activities and loss of consciousness will be investigated as well.

    Time frame: Induction of anesthesia (approx. 10-30 min)

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Study locations

1 site
  • South Karelia Central Hospital
    Lappeenranta, 53130, Finland
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References and documents

Publications

  • 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. PubMed 27749312 ↗
  • 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. PubMed 30788811 ↗
  • 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. PubMed 34111496 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 5, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03943745
Lead sponsor
University of Oulu
Collaborators
South Carelia Central Hospital, Cerenion Oy
Responsible party
Sponsor
First posted
May 9, 2019
Start date
Oct 25, 2018
Primary completion
Mar 28, 2024
Completion
Mar 28, 2024
Last update
May 5, 2026

Study contacts

Jukka Kortelainen, MD, PhD
principal investigator · University of Oulu

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.

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