Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03926650
Recruitment Status : Completed
First Posted : April 24, 2019
Last Update Posted : April 9, 2021
Sponsor:
Information provided by (Responsible Party):
Hakan Gokalp TAS, Erzincan University

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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 Intervention/treatment
Muscle Relaxation Device: Masimo Sedline Monitor Patient State Index

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
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
Actual Study Start Date : March 1, 2019
Actual Primary Completion Date : March 1, 2020
Actual Study Completion Date : August 1, 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Intervention Details:
  • Device: 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
    Other Name: Train Of Four

Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years 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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03926650


Locations
Layout table for location information
Turkey
Erzincan University
Erzincan, Merkez, Turkey, 24000
Sponsors and Collaborators
Erzincan University
Investigators
Layout table for investigator information
Principal Investigator: Hakan G. Taş Mengucek Gazi Education and Research Hospital
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Hakan Gokalp TAS, Research Assistant Doctor Hakan Gökalp TAŞ, Erzincan University
ClinicalTrials.gov Identifier: NCT03926650    
Other Study ID Numbers: ErzincanUnv
First Posted: April 24, 2019    Key Record Dates
Last Update Posted: April 9, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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