Anesthesia, GeneralPropoStatusNCT03943745
EEG Changes During Induction of Propofol Anesthesia
An observational study of Anesthesia, General and Healthy Subjects, run by University of Oulu at 1 site in Finland.
Trial summary
PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Anesthesia, General, Healthy Subjects
- How many people
- 45 participants
- Where
- 1 siteFinland
- Study dates
- 25 Oct 2018to 28 Mar 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Neurologically healthy individuals coming to hospital for elective surgery with general anesthesia
Who may be able to join
- ASA 1-2 (no neurological or cardiovascular diseases)
Who cannot join
- BMI > 30
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of EEG Changes During Induction of Propofol Anesthesia Using Wireless Measurement Devices
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.
- Conditions
- Anesthesia, General, Healthy Subjects
- Keywords
- EEG, Propofol
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Induction of anesthesia (approx. 10-30 min)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start25 Oct 2018
- Primary completion28 Mar 2024
- Study completion28 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, GeneralStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Oulu
- Sponsor type
- University, hospital or other
- Collaborators
- South Carelia Central Hospital, Cerenion Oy
- Responsible party
- Sponsor
- Investigators
- Jukka Kortelainen, MD, PhD, Principal investigator, University of Oulu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943745
- Sponsor's protocol ID
- 31/2018
- Acronym
- PropoStatus
- Status last verified
- Dec 2024
- First submitted
- 7 May 2019
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 27749312Kortelainen 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 30788811Kortelainen 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
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of EEG Changes During Induction of Propofol Anesthesia Using Wireless Measurement Devices
- ClinicalTrials.gov ID
- NCT03943745
- Acronym / sponsor ID
- PropoStatus / 31/2018
- Conditions
- Anesthesia, General, Healthy Subjects
- Keywords
- EEG, Propofol
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- University of OuluUniversity, hospital or other
- Collaborators
- South Carelia Central Hospital, Cerenion Oy
- Study start
- 25 Oct 2018 (actual)
- Primary completion
- 28 Mar 2024 (actual)
- Study completion
- 28 Mar 2024 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PropoStatus is a prospective observational study investigating the EEG changes seen in neurologically healthy patients during induction of general anesthesia with propofol.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Neurologically healthy individuals coming to hospital for elective surgery with general anesthesia
Key inclusion criteria (1 listed)
- ASA 1-2 (no neurological or cardiovascular diseases)
Key exclusion criteria (1 listed)
- BMI > 30
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
EEG slow-wave activity
Time frame: Induction of anesthesia (approx. 10-30 min)
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.
1 secondary outcome
EEG activity on other frequency bands
Time frame: Induction of anesthesia (approx. 10-30 min)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Background: PubMed 27749312Kortelainen 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.
- Background: PubMed 30788811Kortelainen 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.
- Background: PubMed 34111496Kortelainen 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.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, General
Not yet recruitingObservational study
Preoperative Frailty and Suboptimal Mask Ventilation in Cardiac Surgery Patients
Frailty, Suboptimal Mask Ventilation
Recruiting
Effect of a Brief Educational Intervention on Endotracheal Tube Cuff Pressure
Intubation, Endotracheal Tube Cuff Pressure
Not yet recruiting
Comparison of Second- and Third-Generation Laryngeal Mask Airway in Pediatric Patients
Airway Management, Anesthesia, General
Not yet recruitingObservational study
Diaphragm Ultrasound and Neuromuscular Monitoring for Predicting Early Respiratory Events After Extubation
Residual Neuromuscular Blockade, Diaphragm Dysfunction
Recruiting
Pharyngeal Mucosal Conditioning to Prevent Postoperative Sore Throat in Septoplasty Patients With Severe Nasal Obstruction
Postoperative Sore Throat, Nasal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jukka Kortelainen, MD, PhD principal investigator
University of Oulu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Anesthesia, General and Healthy Subjects, run by University of Oulu at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
EEG slow-wave activity (time frame: Induction of anesthesia (approx. 10-30 min)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03943745, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.