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

Muscle Relaxation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03926650
• Other study ID #: ErzincanUnv
• Status: Completed
• Start date: March 1, 2019
• Est. completion date: August 1, 2020

Study information

• Verified date: April 2021
• Source: Erzincan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 1, 2020
• Est. primary completion date: March 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Relaxation

Intervention

Device:
• Masimo Sedline Monitor Patient State Index
Masimo Sedline Monitor shows frontal electromyography and patient state index, Train of four monitor shows muscle strength on adductor pollicis muscle

Locations

Country	Name	City	State
Turkey	Erzincan University	Erzincan	Merkez

Sponsors (1)

Lead Sponsor	Collaborator
Erzincan University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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