Clinical trial NCT03299621: Monitoring of Anesthetic Depth and EEG Band Power Using PLE (Phase Lag Entropy) During Propofol Anesthesia
Official title: Anesthetic Depth Using PLE (Phase Lag Entropy)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Anesthesia, General
Lead sponsor: Korea University Anam Hospital
Sponsor class: OTHER
First posted: 2017-10-03
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: The evaluation of the anesthetic depth monitoring using PLE (Phase Lag Entropy) during propofol anesthesia

Detailed description: The devices using EEG are commonly used for measuring the depth of consciousness during anesthesia. However, the existing devices are largely dependent on the biphasic analysis of 1-channel EEG signals, and thus do not provide proper information for anesthetic 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.

Eligibility criteria: Inclusion Criteria:

* The patients undergoing elective general anesthesia with American Society fo Anesthesiologist (ASA) physical status I or II (20-60 years)

Exclusion Criteria:

* Patients with difficulty airway
* Patients with cardiovascular disease
* Patients with cerebrovascular disease
* Patients with respiratory disease

Primary outcomes:
measure: PLE (Phase Lag Entropy) value before and after intubation
timeFrame: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Secondary outcomes:
measure: PLE value before and after the injection of muscle relaxant
timeFrame: at 3 min after the injection of muscle relaxant, immediately after intubation
measure: PLE value and BIS value at that time of induction and awakening
timeFrame: at the time point of no-response to verbal command during induction (modified Observer's assessment of Alertness/Sedation scale (modified OAA/S scale) = 2, at the time point of response to verbal command during awakening (modified OAA/S scale = 3).
measure: Bispectral index (BIS) value before and after intubation
timeFrame: at the time points that propofol target effect site concentration reach to 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
measure: Band power (Gamma, Beta, Alpha, Theta, and Delta waves) before and after intubation
timeFrame: at the time points that propofol target effect site concentration reach at 0, 2, 4, 5, 6 μg/ml, and the time points before and after intubation
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
state: Inchon-ro 8-gil 73
city: Seoul
country: Korea, Republic of
facility: Korea University Anam Hospital
Study officials:
affiliation: Korea University Anam Hospital, Seoul, Inchon-ro 8-gil 73, Seoul, Republic of Korea
name: Hye-Won Shin, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.