Monitoring of Anesthetic Depth and EEG Band Power Using PLE (Phase Lag Entropy) During Propofol Anesthesia

Anesthesia, General Clinical Trial

— PLE  

Official title:

Anesthetic Depth Using PLE (Phase Lag Entropy)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03299621
• Other study ID #: MD17014
• Status: Recruiting
• Phase: N/A
• First received: August 25, 2017
• Last updated: November 13, 2017
• Start date: November 13, 2017
• Est. completion date: August 31, 2018

Study information

• Verified date: November 2017
• Source: Korea University Anam Hospital
• Contact: Hyun-Jung Kim, M.D.
• Phone: 821033859168
• Email: k87876655[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: August 31, 2018
• Est. primary completion date: August 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia, General

Intervention

Device:
• PLE (Phase Lag Entropy)
Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.

Drug:
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Korea University Anam Hospital	Seoul	Inchon-ro 8-gil 73
Korea, Republic of	Korea University Anam Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Korea University Anam Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PLE (Phase Lag Entropy) value before and after intubation	Investigators measure the PLE value 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.	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	PLE value before and after the injection of muscle relaxant	Investigators measure the PLE value before the injection of muscle relaxant, at 3 min after the injection of muscle relaxant, and immediately after intubation.	at 3 min after the injection of muscle relaxant, immediately after intubation
Secondary	PLE value and BIS value at that time of induction and awakening	Investigators measure the PLE value and BIS value 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].	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).
Secondary	Bispectral index (BIS) value before and after intubation	Investigators measure the Bispectral index (BIS) value at 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.	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	Band power (Gamma, Beta, Alpha, Theta, and Delta waves) before and after intubation	Investigators calculate band power from the data file at the time points that propofol target effect site concentration reach 0, 2, 4, 5, 6 µg/ml, and the time points before and after intubation.	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