An observational study in Muscle Relaxation, sponsored by Erzincan University. Completed at 1 site in Turkey. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2021-04-09.
Sponsored by Erzincan University · Observational
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.
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.
Erzincan University is the lead sponsor of 42 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
the patients wha has surgery continues more then 1 hour
Exclusion Criteria:
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
Patient State Index
Measures anaesthetic awakeness. It can be between 0-100. The investigators will record this parameter after using the reversal drugs
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 minutes
Plan to share: No
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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Erzincan University