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Completed

NCT Number: NCT03926650

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

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.

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Key information

Conditions

Muscle Relaxation

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Erzincan University

Erzincan, Merkez, 24000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Masimo Sedline Monitor Patient State Index

Device

Masimo Sedline Monitor shows frontal electromyography and patient state index, Train of four monitor shows muscle strength on adductor pollicis muscle

Other names: Train Of Four

Primary outcomes

  1. Patient State Index

    Time frame: 0 minutes

    Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs

  2. Patient State Index

    Time frame: 1 minutes

    Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs

  3. Patient State Index

    Time frame: 2 minutes

    Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs

  4. Patient State Index

    Time frame: 3 minutes

    Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs

  5. Patient State Index

    Time frame: 4 minutes

    Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs

  6. Patient State Index

    Time frame: 5 minutes

    Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs

  7. Electromyography (Frontal EMG)

    Time frame: 0 minutes

    Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs

  8. Electromyography (Frontal EMG)

    Time frame: 1 minutes

    Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs

  9. Electromyography (Frontal EMG)

    Time frame: 2 minutes

    Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs

  10. Electromyography (Frontal EMG)

    Time frame: 3 minutes

    Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs

  11. Electromyography (Frontal EMG)

    Time frame: 4 minutes

    Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs

  12. Electromyography (Frontal EMG)

    Time frame: 5 minutes

    Measures frontal muscles' strength.It can be between % 0 - %100. The investigators will record this parameter after using the reversal drugs

Sponsors and collaborators

Lead sponsor

Erzincan University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2019
Registry last updated
Apr 9, 2021

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

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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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