Clinical trial NCT03943745: EEG Changes During Induction of Propofol Anesthesia
Official title: Assessment of EEG Changes During Induction of Propofol Anesthesia Using Wireless Measurement Devices
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Anesthesia, General
Healthy Subjects
Keywords: EEG
Propofol
Lead sponsor: University of Oulu
Sponsor class: OTHER
Collaborators: name: South Carelia Central Hospital
name: Cerenion Oy
First posted: 2019-05-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Neurologically healthy individuals coming to hospital for elective surgery with general anesthesia

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria

* BMI \> 30

Primary outcomes:
measure: EEG slow-wave activity
timeFrame: Induction of anesthesia (approx. 10-30 min)
Secondary outcomes:
measure: EEG activity on other frequency bands
timeFrame: Induction of anesthesia (approx. 10-30 min)
Other outcomes:
Locations:
city: Lappeenranta
country: Finland
facility: South Karelia Central Hospital
Study officials:
affiliation: University of Oulu
name: Jukka Kortelainen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.