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

NCT ID: NCT03926650

Last Updated: 2021-04-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-03-01

Study Completion Date

2020-08-01

Brief Summary

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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

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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.

Conditions

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Muscle Relaxation

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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Train Of Four

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Erzincan University

OTHER

Sponsor Role lead

Responsible Party

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Hakan Gokalp TAS

Research Assistant Doctor Hakan Gökalp TAŞ

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hakan G. Taş

Role: PRINCIPAL_INVESTIGATOR

Mengucek Gazi Education and Research Hospital

Locations

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Erzincan University

Erzincan, Merkez, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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ErzincanUnv

Identifier Type: -

Identifier Source: org_study_id

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