search
Back to results

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

Primary Purpose

General Anesthetic Drug Overdose

Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
BIS-PLE
Sponsored by
Pusan National University Yangsan Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for General Anesthetic Drug Overdose focused on measuring EMG, BIS, phase lag entropy

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Pusan National University Yangsan Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BIS-PLE

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The difference between BIS and phase lag entropy during general anesthesia
BIS uses the frequency, amplitude, phase angle of electroencephalogram, and measures the coherence. Finally, it is closely related to the level of sedation and consciousness by the anesthetic agent. PLEM 100 is 4-channel electroencephalogram monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist continuously monitor the state of consciousness and muscle relaxation from entrance of the patient to the complete recovery of muscle relaxation.

Full Information

First Posted
July 16, 2017
Last Updated
April 4, 2018
Sponsor
Pusan National University Yangsan Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT03230929
Brief Title
The Effect of Electromyogram (EMG) Activity on Anesthetic Depth Monitoring
Official Title
The Effect of EMG Activity on Anesthetic Depth Monitoring : Comparison Between Phase Lag Entropy and BIS
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
December 30, 2017 (Actual)
Study Completion Date
December 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pusan National University Yangsan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Intravenous administration of 2% propofol and remifentanil would be done for total intravenous anesthesia. After intravenous injection of rocuronium 0.6 mg/ kg for muscle relaxation, endotracheal intubation would be performed. Then, 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. Before the end of surgery, the degree of neuromuscular relaxation should be within deep block (TOF count <2) and the concentration of 2% propofol should be adjusted for maintaining BIS between 50 and 60. 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, monitor and record the values of BIS, phase lag entropy monitor (PLEM) 100, and neuromuscular monitoring in 1 minute increments for 5 minutes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthetic Drug Overdose
Keywords
EMG, BIS, phase lag entropy

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BIS-PLE
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
BIS-PLE
Intervention Description
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.
Primary Outcome Measure Information:
Title
The difference of phase lag entropy between before and after neuromuscular recovery
Description
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.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
The difference between BIS and phase lag entropy during general anesthesia
Description
BIS uses the frequency, amplitude, phase angle of electroencephalogram, and measures the coherence. Finally, it is closely related to the level of sedation and consciousness by the anesthetic agent. PLEM 100 is 4-channel electroencephalogram monitor and it records electric activity signals of the brain generated from the human body. The anesthesiologist continuously monitor the state of consciousness and muscle relaxation from entrance of the patient to the complete recovery of muscle relaxation.
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: The patient who is scheduled for operation requiring general anesthesia and whose American Society of Anesthesiologists (ASA) status is I or II. Exclusion Criteria: Who has neuromuscular disease Who takes medicines related neurologic system
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tae-Kyun Kim, PhD.
Organizational Affiliation
Pusan National University Yangsan Hospital, Geumo-ro 20, Mulgeum-eup, Yangsan, 50612
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pusan National University Yangsan Hospital
City
Yangsan
ZIP/Postal Code
50612
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs