Clinical trial NCT03926650: The Correlation Between the Frontal Electromyography Parameter in Patient State Index (PSI) Monitor and Train of Four
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Muscle Relaxation
Lead sponsor: Erzincan University
Sponsor class: OTHER
First posted: 2019-04-24
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: the patients wha has surgery continues more then 1 hour

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient State Index
timeFrame: 0 minutes
measure: Patient State Index
timeFrame: 1 minutes
measure: Patient State Index
timeFrame: 2 minutes
measure: Patient State Index
timeFrame: 3 minutes
measure: Patient State Index
timeFrame: 4 minutes
measure: Patient State Index
timeFrame: 5 minutes
measure: Electromyography (Frontal EMG)
timeFrame: 0 minutes
measure: Electromyography (Frontal EMG)
timeFrame: 1 minutes
measure: Electromyography (Frontal EMG)
timeFrame: 2 minutes
measure: Electromyography (Frontal EMG)
timeFrame: 3 minutes
measure: Electromyography (Frontal EMG)
timeFrame: 4 minutes
measure: Electromyography (Frontal EMG)
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Erzincan
country: Turkey
facility: Erzincan University
state: Merkez
Study officials:
affiliation: Mengucek Gazi Education and Research Hospital
name: Hakan G. Taş
role: PRINCIPAL_INVESTIGATOR
References: