The Correlation Between the Frontal Electromyography Parameter in Patient State Index (PSI) Monitor and Train of Four

Correlation of Train Of Four (TOF) With Frontal EMG Parameter Measured by Patient State Index (PSI) Monitor in Extubation Phase of General Anesthesia

The Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. After the induction of general anaesthesia the investigators will wait for disappearance of eyelash reflex. TOF monitor will be calibrated and muscle relaxant will be applied. After TOF is %0 and disappearance of thumb movement the patient will be intubated. After surgery the investigators will apply muscle relaxant reversal drugs. Then the investigators will record PSI and EMG parameters when TOF is %0, %25, %50,%75,%90. When TOF is %90 the investigators will extubate the patient. The investigators will record PSI and EMG parameters after 5 minutes.

Study Overview

• Status: Completed
• Conditions: Muscle Relaxation
• Intervention / Treatment: Device: Masimo Sedline Monitor Patient State Index

Detailed Description

The study is planned prospective and observational. The study started after approval of Erzincan Binali Yıldırım University Ethics Committee and taking written approval of patients. The study includes 84 patients who has surgery continues more then 1 hour, who is between ages 18-65, who is ASA I,II and III. The patients who has allergical reactions of the drugs used, neurological or neuromuscular diseases,the patients who use drugs effecting the neuromuscular junction, pregnant patients, electrolyte disregulations, major organ failures, liver failure, kidney failure, obese and cachectic patients are excluded from the study.

All patients will be informed and signed written approval 1 day before the surgery. Patients will be taken to the operating room, venous catheter will be applied on antecubital area. 3 channel EKG , SpO2 Monitor and noninvasive blood pressure monitorisation will be applied. The patients will be taken 2-4 litres of O2 with nasal cannula .The Train Of Four (TOF) Monitor will be placed on ulnar nerve on right wrist of the patients who has surgery under general anaesthesia. This is for stimulation of adductor pollicis muscle. Sedline (Masimo Electromyography(EMG) and Patient State Index(PSI)) Monitor will be placed on the frontal area of head. After the induction of general anaesthesia the investigators will wait for disappearance of eyelash reflex. TOF monitor will be calibrated and muscle relaxant will be applied. After TOF is %0 and disappearance of thumb movement the patient will be intubated. After surgery the investigators will apply muscle relaxant reversal drugs. PSI and EMG parameters will be recorded when TOF is %0, %25, %50,%75,%90. When TOF is %90 the investigators will extubate the patient. PSI and EMG parameters will be recorded after 5 minutes. The patient will be taken to the PACU room. On 5,10,30 minutes after surgery, the investigators will record aldrete score of patients.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Turkey
  • Merkez
    • Erzincan, Merkez, Turkey, 24000
      • Erzincan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

the patients wha has surgery continues more then 1 hour

Description

Inclusion Criteria:

• surgery continues more then 1 hour
• between ages 18-65
• ASA I,II and III patients

Exclusion Criteria:

• The patients who has allergical reactions of the drugs used
• neurological or neuromuscular diseases
• the patients who use drugs effecting the neuromuscular junction
• pregnant patients
• electrolyte disregulations
• major organ failures, liver failure, kidney failure
• obese and cachectic patients

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient State Index	Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs	0 minutes
Patient State Index	Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs	1 minutes
Patient State Index	Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs	2 minutes
Patient State Index	Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs	3 minutes
Patient State Index	Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs	4 minutes
Patient State Index	Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs	5 minutes
Electromyography (Frontal EMG)	Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs	0 minutes
Electromyography (Frontal EMG)	Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs	1 minutes
Electromyography (Frontal EMG)	Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs	2 minutes
Electromyography (Frontal EMG)	Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs	3 minutes
Electromyography (Frontal EMG)	Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs	4 minutes
Electromyography (Frontal EMG)	Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs	5 minutes

Collaborators and Investigators

• Sponsor: Erzincan University
• Investigators: Principal Investigator: Hakan G. Taş, Mengucek Gazi Education and Research Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 1, 2019
• Primary Completion (ACTUAL): March 1, 2020
• Study Completion (ACTUAL): August 1, 2020

Study Registration Dates

• First Submitted: April 18, 2019
• First Submitted That Met QC Criteria: April 22, 2019
• First Posted (ACTUAL): April 24, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 9, 2021
• Last Update Submitted That Met QC Criteria: April 7, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: ErzincanUnv

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes