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

NCT03926650 | Completed FDA Device

• 1 other identifier: ErzincanUnv
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Relaxation

Outcome Measures

Primary Outcomes (12)

• 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

Interventions

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

Also known as: Train Of Four

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

the patients wha has surgery continues more then 1 hour

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erzincan University: lead

Study Sites (1)

Erzincan University

Erzincan, Merkez, 24000, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Neuromuscular Monitoring

Intervention Hierarchy (Ancestors)

Monitoring, Physiologic; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Hakan G. Taş

  Mengucek Gazi Education and Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Doctor Hakan Gökalp TAŞ

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 24, 2019
• Study Start: March 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: August 1, 2020
• Last Updated: April 9, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)