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

Anesthetic Depth Using PLE (Phase Lag Entropy)

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

Study Overview

• Status: Unknown
• Conditions: Anesthesia, General
• Intervention / Treatment: Device: PLE (Phase Lag Entropy); Drug: Muscle Relaxant

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.

• Study Type: Interventional
• Enrollment (Anticipated): 35
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hyun-Jung Kim, M.D.; Phone Number: 821033859168; Email: k87876655@gmail.com
• Study Contact Backup: Name: Hye-Won Shin, Ph.D.; Phone Number: 821092735025; Email: drhwshin@naver.com

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Recruiting
    • Korea University Anam Hospital
    • Contact: Hye Won Shin, M.D., PhD.
  • Inchon-ro 8-gil 73
    • Seoul, Inchon-ro 8-gil 73, Korea, Republic of, 02841
      • Recruiting
      • Korea University Anam Hospital
      • Contact: Hye-Won Shin, Ph.D.; Phone Number: 821092735025; Email: drhwshin@naver.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 58 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PLE (Phase Lag Entropy) monitoring; Investigators monitor the change of PLE value using the sensor of PLEM™ during propofol anesthesia.	Device: PLE (Phase Lag Entropy); Monitoring of PLE value using the monitoring of PLEM™ device during propofol anesthesia.; Other Names: PLEM™ (Inbody co., ltd)
Experimental: Muscle relaxant injection; Investigators monitor the change for PLE value using the sensor of PLEM™ before and after the injection of muscle relaxant.	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.; Other Names: Muscle relaxant (rocuronium)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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).
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
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

Collaborators and Investigators

• Sponsor: Korea University Anam Hospital
• Investigators: Principal Investigator: Hye-Won Shin, Ph.D., Korea University Anam Hospital, Seoul, Inchon-ro 8-gil 73, Seoul, Republic of Korea

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2017
• Primary Completion (Anticipated): August 31, 2018
• Study Completion (Anticipated): August 31, 2018

Study Registration Dates

• First Submitted: August 25, 2017
• First Submitted That Met QC Criteria: September 27, 2017
• First Posted (Actual): October 3, 2017

Study Record Updates

• Last Update Posted (Actual): November 14, 2017
• Last Update Submitted That Met QC Criteria: November 13, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Peripheral Nervous System Agents; Neuromuscular Agents; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Rocuronium
• Other Study ID Numbers: MD17014

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No