EEG Changes During Induction of Propofol Anesthesia

Healthy Subjects Clinical Trial

— PropoStatus  

Official title:

Assessment of EEG Changes During Induction of Propofol Anesthesia Using Wireless Measurement Devices

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03943745
• Other study ID #: 31/2018
• Status: Recruiting
• Start date: October 25, 2018
• Est. completion date: May 2024

Study information

• Verified date: November 2023
• Source: University of Oulu
• Contact: Jukka Kortelainen, MD, PhD
• Phone: +358 50 4474909
• Email: jukka.kortelainen[@]oulu.fi
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria

• BMI > 30

Related Conditions & MeSH terms

• Anesthesia, General
• Healthy Subjects

Locations

Country	Name	City	State
Finland	South Karelia Central Hospital	Lappeenranta

Sponsors (3)

Lead Sponsor	Collaborator
University of Oulu	Cerenion Oy, South Carelia Central Hospital

Country where clinical trial is conducted

Finland, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Induction of anesthesia (approx. 10-30 min)