Monitoring of Anesthetic Depth and EEG Band Power Using PLE (Phase Lag Entropy) During Propofol Anesthesia
NCT ID: NCT03299621
Last Updated: 2017-11-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
35 participants
INTERVENTIONAL
2017-11-13
2018-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Recent study reported that the complexity or diversity of communication between the brain regions is related to the level of consciousness. In particular, during anesthesia, the phase synchronization (phase shift) between EEG signals at the front of the brain increases, indicating a reduction in communication diversity and a close relationship with loss of consciousness. Therefore, to predict the depth of sleep, a technique for precisely quantifying the complexity of inter-domain communication in the frontal brain is needed. Recently, PLEM™ (Inbody co., ltd, Republic of Korea), developed using the phase lag entropy (PLE), is a 4-channel EEG monitoring device that measures the entropy of the phase difference pattern between two channels of prefrontal and frontal brain. In addition, PLEM™ is able to observe changes in band power of EEG (Gamma, Beta, Alpha, Theta, and Delta waves). As the depth of anesthesia increases, the amplitude and frequency of EEG decreases. Generally, Beta waves (13-30 Hz) are seen in awake conscious patients and Alpha waves (8-12 Hz) are seen in patients resting with eyes closed. And Theta waves (4-7 Hz) and Delta waves (0-3 Hz) can be present in a patient who is sleeping or anesthetized.
The purpose of this study was to evaluate the efficacy for anesthetic depth monitoring of PLEM™ monitor during propofol anesthesia. The primary outcome of this study was to investigate the changes of PLE value and band power of EEG (Gamma, Beta, Alpha, Theta, Delta waves) on the PLEM™ monitor while varying the depth of anesthesia using propofol target controlled infusion (TCI) during anesthetic induction. The secondary outcomes of this study were to investigate whether the muscle relaxant affects the PLE value, and to compare the PLE values with BIS (bispectral index) (Aspect medical system, USA) that was the most widely used to measure the depth of anesthesia.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
OTHER
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
PLE (Phase Lag Entropy) monitoring
Investigators monitor the change of PLE value using the sensor of PLEM™ during propofol anesthesia.
PLE (Phase Lag Entropy)
Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.
Muscle relaxant injection
Investigators monitor the change for PLE value using the sensor of PLEM™ before and after the injection of muscle relaxant.
Muscle Relaxant
Monitoring of PLE value using the monitoring of PLEM™ device before and after the injection of muscle relaxant that used for tracheal intubation.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
PLE (Phase Lag Entropy)
Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.
Muscle Relaxant
Monitoring of PLE value using the monitoring of PLEM™ device before and after the injection of muscle relaxant that used for tracheal intubation.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Patients with cardiovascular disease
* Patients with cerebrovascular disease
* Patients with respiratory disease
20 Years
60 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Korea University Anam Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Hye-Won Shin
Department of Anesthesiology and Pain Medicine
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hye-Won Shin, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Korea University Anam Hospital, Seoul, Inchon-ro 8-gil 73, Seoul, Republic of Korea
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Korea University Anam Hospital
Seoul, Inchon-ro 8-gil 73, South Korea
Korea University Anam Hospital
Seoul, , South Korea
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Hye-Won Shin, Ph.D.
Role: primary
Hye Won Shin, M.D., PhD.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Shin HW, Kim HJ, Jang YK, You HS, Huh H, Choi YJ, Choi SU, Hong JS. Monitoring of anesthetic depth and EEG band power using phase lag entropy during propofol anesthesia. BMC Anesthesiol. 2020 Feb 26;20(1):49. doi: 10.1186/s12871-020-00964-5.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
MD17014
Identifier Type: -
Identifier Source: org_study_id