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

NCT03424720 | Unknown

• 1 other identifier: 3-2017-10047988
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

General Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• BIS value during induction and emergence of general anesthesia

  Through study completion, an average of fifteen months

• PLE value during facial nerve integrity monitoring

  Through study completion, an average of fifteen months

• BIS value during facial nerve integrity monitoring

  Through study completion, an average of fifteen months

Study Arms (1)

Comparison of PLE and BIS

EXPERIMENTAL

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

Interventions

PLE and BIS DEVICE

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

Comparison of PLE and BIS

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hallym University Medical Center: lead

Study Sites (1)

Hallym University Medical Center

Anyang-si, Gyeonggi-do, South Korea

RECRUITING

Study Officials

• Kyung Mi Kim, Ph.D.

  Department of Anesthesiology and Pain Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Mi Kim, Ph.D.

CONTACT

82313803945; sumsonyo@hallym.or.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff, Department of Anesthesiology and pain Medicine, Principal Investigator, Assistant Professor.

Study Record Dates

• First Submitted: January 17, 2018
• First Posted: February 7, 2018
• Study Start: August 2, 2017
• Primary Completion: October 31, 2018
• Study Completion: October 31, 2018
• Last Updated: February 7, 2018

Record last verified: 2018-02

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)