Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator

Comparative Analysis of Phase Lag Entropy (PLE) and Bispectral Index (BIS) as an Anesthetic Depth Indicator in Patients Undergoing Otopharyngeal Surgery With Facial Nerve Integrity Monitoring

The aim of this comparative analysis is to evaluate the reliability of PLE value as an anesthetic depth indicator

Study Overview

• Status: Unknown
• Conditions: General Anesthesia
• Intervention / Treatment: Device: PLE and BIS

Detailed Description

1. To evaluate the reliability of PLE value as an anesthetic depth indicator, the investigators compare PLE value with BIS score during induction and emergence of general anesthesia using propofol target controlled infusion.
2. In addition, the investigators verify whether or not the facial nerve integrity monitoring affects the efficacy for PLE and BIS values as an anesthetic depth indicator.

• Study Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi-do
    • Anyang-si, Gyeonggi-do, Korea, Republic of
      • Recruiting
      • Hallym University Medical Center
      • Contact: Kyung Mi Kim, Ph.D.; Phone Number: 82313803945
      • Principal Investigator: Kyung Mi Kim, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients who scheduled for otopharyngeal surgery under facial nerve integrity monitoring requiring general anesthesia and American Society of Anesthesiology (ASA) physical status 1 or 2

Exclusion Criteria:

• Patient who has been taken anticonvulsant agents, sedatives, and hypnotics
• Patient who has central nerve system disease, neurological disorder
• Patient with hypersensitivity to anesthetics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Comparison of PLE and BIS; Investigators assess PLE and BIS values as indicators of the depth of anesthesia during induction and emergence of anesthesia and facial nerve integrity monitoring	Device: PLE and BIS; Investigators attach the PLE and BIS sensors on the forehead of the patients undergoing facial nerve integrity monitoring during general anesthesia using total intravenous anesthetics

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PLE value during induction and emergence of general anesthesia	Investigators measure the PLE value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia. The PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).	Through study completion, an average of fifteen months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BIS value during induction and emergence of general anesthesia	Investigators measure the BIS value as an anesthetic depth indicator before the injection of propofol, at the time point of no response to verbal command, before and after intubation, and at the time point of response to verbal command during emergence of anesthesia. The BIS value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).	Through study completion, an average of fifteen months
PLE value during facial nerve integrity monitoring	Investigators measure the PLE value at the time points of facial nerve integrity monitoring. The PLE value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).	Through study completion, an average of fifteen months
BIS value during facial nerve integrity monitoring	Investigators measure the BIS value at the time points of facial nerve integrity monitoring. The BIS value will be reported in a score ranging from 0 (burst suppression or deep sedated) to 100 (full awake).	Through study completion, an average of fifteen months

Collaborators and Investigators

• Sponsor: Hallym University Medical Center
• Investigators: Principal Investigator: Kyung Mi Kim, Ph.D., Department of Anesthesiology and Pain Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 2, 2017
• Primary Completion (Anticipated): October 31, 2018
• Study Completion (Anticipated): October 31, 2018

Study Registration Dates

• First Submitted: January 17, 2018
• First Submitted That Met QC Criteria: February 5, 2018
• First Posted (Actual): February 7, 2018

Study Record Updates

• Last Update Posted (Actual): February 7, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 3-2017-10047988

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

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