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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/27/2021.

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

Clinicaltrials.gov identifier NCT03926650

Recruitment Status Recruiting

First Posted April 24, 2019

Last update posted April 24, 2019

Study Description

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.

  • Condition or Disease:Muscle Relaxation
  • Intervention/Treatment: Device: Masimo Sedline Monitor Patient State Index
  • Phase: N/A
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.

Study Design
  • Study Type: Observational [Patient Registry]
  • Estimated Enrollment: 84 participants
  • Observational Model: Case-Control
  • Time Perspective: Prospective
  • Official Title: The Correlation Between the Frontal Electromyography Parameter in Patient State Index (PSI) Monitor and Muscle Strength Monitor With Train of Four (TOF) in Patients Under General Anaesthesia
  • Actual Study Start Date: March 2019
  • Estimated Primary Completion Date: March 2020
  • Estimated Study Completion Date: August 2020
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • 2. 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
  • 3. 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
  • 4. 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
  • 5. 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
  • 6. 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
  • 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
Eligibility Criteria
  • Ages Eligible for Study: 18 to 65 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Probability Sample
  • Study Population: the patients wha has surgery continues more then 1 hour
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

Contacts and Locations
Contacts

Contact: Hakan G. Taş +905412736633 hakangokalptas@hotmail.com

Locations

Turkey, Merkez
Erzincan University
Erzincan

Sponsors and Collaborators

Erzincan University

Investigators

Principal Investigator: Hakan G. Taş Mengucek Gazi Education and Research Hospital

More Information
  • Responsible Party: Erzincan University
  • ClinicalTrials.gov Identifier: NCT03926650 History of Changes
  • Other Study ID Numbers: ErzincanUnv
  • First Posted: April 24, 2019 Key Record Dates
  • Last Update Posted: April 24, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: Yes
  • Product Manufactured in and Exported from the U.S.: Yes