About Bolder Science

Our mission is to provide healthcare professionals with unbiased clinical research information, easily.

Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.
This website is for US healthcare professionals

Log In to Bolder Science

or

Don't have an account? Sign Up

Please enter your email address.

You will receive a link to create a new password via email.

Log In

Create an Account

or
(optional) ?

Welcome, !

Please complete the following 4 questions to ensure you receive the information that best suits your needs.

Clinical Trials of Interest

When I’m looking for information on clinical trials, I usually am interested in...

finding clinical trials in which to enroll my patients

Rarely Often

finding newly launched clinical trials (for all phases)

Rarely Often

updates on status changes for clinical trials

Rarely Often

pipeline molecules

Rarely Often

Drug Interventions

Enter up to 3 drug interventions you are currently interested in:

Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/21/2021.

EEG Changes During Induction of Propofol Anesthesia

Clinicaltrials.gov identifier NCT03943745

Recruitment Status Completed

First Posted May 9, 2019

Last update posted May 9, 2019

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:Anesthesia, General
    Healthy Subjects
  • Intervention/Treatment:
  • Phase: N/A
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 self-adhesive disposable forehead electrode and 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.

Study Design
  • Study Type: Observational
  • Actual Enrollment: 20 participants
  • Observational Model: Case-Only
  • Time Perspective: Prospective
  • Official Title: Assessment of Frontal EEG Changes Using Self-adhesive Disposable Forehead Electrode and Wireless Measurement Device During Induction of Propofol Anesthesia
  • Actual Study Start Date: October 2018
  • Actual Primary Completion Date: February 2019
  • Actual Study Completion Date: February 2019
Outcome Measures
  • Primary Outcome Measures: 1. 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.
  • Secondary Outcome Measures: 1. EEG activity on other frequency bands [ Time Frame: 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
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Non-Probability Sample
  • Study Population: Neurologically healthy individuals coming to hospital for elective surgery with general anesthesia
Criteria

Inclusion Criteria:

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

Exclusion Criteria

- BMI > 30

Contacts and Locations
Contacts
Locations

Finland
South Karelia Central Hospital
Lappeenranta

Sponsors and Collaborators

University of Oulu

South Carelia Central Hospital

Cerenion Oy

Investigators

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

More Information