The Effect of Electromyogram (EMG) Activity on Anesthetic Depth Monitoring

NCT03230929 | Completed

• 1 other identifier: L-2017-165
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Currently, a lot of equipments based on Bispectral index (BIS) is used clinically in order to measure the depth of anesthesia. Although BIS is used for the measurement of the presence of consciousness or degree of sedation during general anesthesia, it could be influenced by factors that affect or interfere with the activity of EEG because it is a numerical value which is measured by analyzing EEG. The BIS electrode for EEG analysis should be attached to the patient's forehead and the EEG signal is 0.5 - 30 Hz, the EMG signal is 30 - 300 Hz, and the BIS analyzes the 0 - 47 Hz signal. Therefore, 30 -47 Hz EMG signal may influence the BIS value and the BIS value may differ from the actual. In patients with complete muscle relaxation, the change in BIS varies in proportion to the concentration of anesthetic, but in a state with less muscle relaxation or arousal period of anesthesia when recovery of muscle relaxation occurs, BIS value may not accurately reflects the change in the depth of anesthesia. Although there is a study on the influence of the degree of muscle relaxation on BIS value, there is no study on whether phase lag entropy (PLE) measuring anesthesia depth based on different mechanism from BIS is affected by status of muscle relaxation. After measuring BIS and PLE at the same time, I will compare both of them and investigate the reliability of the measurement of the depth of anesthesia of PLE and how electromyogram activity affects PLE.

Conditions

General Anesthetic Drug Overdose

Keywords

EMG, BIS, phase lag entropy

Outcome Measures

Primary Outcomes (1)

• The difference of phase lag entropy between before and after neuromuscular recovery

  PLEM 100 is 4-channel electroencephalogram (EEG) monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist administers sugammadex intravenously at the end of the surgery, and then monitors and records the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes until neuromuscular recovery is completed.

  24 hours

Secondary Outcomes (1)

• The difference between BIS and phase lag entropy during general anesthesia

  24 hours

Study Arms (1)

BIS-PLE

EXPERIMENTAL

Anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and monitor the monitor and record the values of BIS, PLEM 100, and neuromuscular monitoring.

Device: BIS-PLE

Interventions

BIS-PLE DEVICE

Anesthesiologist attaches the sensors of BIS and PLEM 100 on the forehead of the patient, and adheres the neuromuscular monitoring device on the medial side of the wrist and the ipsilateral thumb to continuously monitor the state of consciousness and muscle relaxation before, during and after surgery. Reversal of muscle relaxant could be performed by intravenous injection of sugammadex 4 mg/ kg in the case of deep neuromuscular relaxation, and 2 mg / kg in the case of shallow muscle relaxation degree under neuromuscular monitoring. After then, they monitor and record the values of BIS, PLEM 100, and neuromuscular monitoring in 1 minute increments for 5 minutes.

BIS-PLE

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient who is scheduled for operation requiring general anesthesia and whose American Society of Anesthesiologists (ASA) status is I or II.

You may not qualify if:

• Who has neuromuscular disease
• Who takes medicines related neurologic system

Sponsors & Collaborators

• Pusan National University Yangsan Hospital: lead

Study Sites (1)

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

Location

Study Officials

• Tae-Kyun Kim, PhD.

  Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup, Yangsan, 50612

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 16, 2017
• First Posted: July 27, 2017
• Study Start: August 1, 2017
• Primary Completion: December 30, 2017
• Study Completion: December 31, 2017
• Last Updated: April 6, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)