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NCT Number: NCT03230929

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

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.

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Key information

Conditions

General Anesthetic Drug Overdose

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pusan National University Yangsan Hospital

Yangsan, 50612, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 24 hours

    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 outcomes

  1. The difference between BIS and phase lag entropy during general anesthesia

    Time frame: 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Pusan National University Yangsan Hospital

Other

Registry information

Official study title

The Effect of EMG Activity on Anesthetic Depth Monitoring : Comparison Between Phase Lag Entropy and BIS

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Jul 27, 2017
Registry last updated
Apr 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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