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

General Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03424720
• Other study ID #: 3-2017-10047988
• Status: Recruiting
• Phase: N/A
• First received: January 17, 2018
• Last updated: February 5, 2018
• Start date: August 2, 2017
• Est. completion date: October 31, 2018

Study information

• Verified date: February 2018
• Source: Hallym University Medical Center
• Contact: Kyung Mi Kim, Ph.D.
• Phone: 82313803945
• Email: sumsonyo[@]hallym.or.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 31, 2018
• Est. primary completion date: October 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• General Anesthesia

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Medical Center	Anyang-si	Gyeonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
Hallym University Medical Center

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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