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

• Sponsor: Erzincan University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03926650
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Actual Duration (Months): 17.1
• Patients Per Site Per Month: 5.9

Study Details

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	Intervention/Treatment	Phase
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

• Study Type: Observational [Patient Registry]
• Actual Enrollment: 100 participants
• Observational Model: Case-Control
• Time Perspective: Prospective
• 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: Mar 1, 2019
• Actual Primary Completion Date: Mar 1, 2020
• Actual Study Completion Date: Aug 1, 2020

Outcome Measures

Primary Outcome Measures

1. Patient State Index [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 [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 [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 [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 [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 [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) [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) [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) [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) [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) [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) [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

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	Erzincan University	Erzincan	Merkez	Turkey	24000

Sponsors and Collaborators

• Erzincan University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hakan Gokalp TAS, Research Assistant Doctor Hakan Gökalp TAŞ, Erzincan University
• ClinicalTrials.gov Identifier: NCT03926650
• Other Study ID Numbers: ErzincanUnv
• First Posted: Apr 24, 2019
• Last Update Posted: Apr 9, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• 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

Study Results

No Results Posted as of Apr 9, 2021