PropoStatus: EEG Changes During Induction of Propofol Anesthesia

Sponsor
University of Oulu (Other)
Overall Status
Recruiting
CT.gov ID
NCT03943745
Collaborator
South Carelia Central Hospital (Other), Cerenion Oy (Industry)
50
1
47.2
1.1

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase

    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

    Study Type:
    Observational
    Anticipated Enrollment :
    50 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Prospective
    Official Title:
    Assessment of EEG Changes During Induction of Propofol Anesthesia Using Wireless Measurement Devices
    Actual Study Start Date :
    Oct 25, 2018
    Anticipated Primary Completion Date :
    Oct 1, 2022
    Anticipated Study Completion Date :
    Oct 1, 2022

    Outcome Measures

    Primary Outcome Measures

    1. EEG slow-wave activity [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.

    Secondary Outcome Measures

    1. EEG activity on other frequency bands [Induction of anesthesia (approx. 10-30 min)]

      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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ASA 1-2 (no neurological or cardiovascular diseases)

    Exclusion Criteria

    • BMI > 30

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 South Karelia Central Hospital Lappeenranta Finland 53130

    Sponsors and Collaborators

    • University of Oulu
    • South Carelia Central Hospital
    • Cerenion Oy

    Investigators

    • Principal Investigator: Jukka Kortelainen, MD, PhD, University of Oulu

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Oulu
    ClinicalTrials.gov Identifier:
    NCT03943745
    Other Study ID Numbers:
    • 31/2018
    First Posted:
    May 9, 2019
    Last Update Posted:
    Jul 6, 2022
    Last Verified:
    Jul 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by University of Oulu

    Study Results

    No Results Posted as of Jul 6, 2022