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The Correlation Between the Frontal Electromyography Parameter in Patient State Index (PSI) Monitor and Train of Four
| Condition or disease | Intervention/treatment |
|---|---|
| Muscle Relaxation | Device: Masimo Sedline Monitor Patient State Index |
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 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 |
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
- 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
| Tracking Information | |||||||
|---|---|---|---|---|---|---|---|
| First Submitted Date | April 18, 2019 | ||||||
| First Posted Date | April 24, 2019 | ||||||
| Last Update Posted Date | April 9, 2021 | ||||||
| Actual Study Start Date | March 1, 2019 | ||||||
| Actual Primary Completion Date | March 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||
| Change History | |||||||
| Current Secondary Outcome Measures | Not Provided | ||||||
| Original Secondary Outcome Measures | Not Provided | ||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||
| Descriptive Information | |||||||
| Brief Title | The Correlation Between the Frontal Electromyography Parameter in Patient State Index (PSI) Monitor and Train of Four | ||||||
| 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 | ||||||
| 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. | ||||||
| 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. |
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| Study Type | Observational [Patient Registry] | ||||||
| Study Design | Observational Model: Case-Control Time Perspective: Prospective |
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| Target Follow-Up Duration | 1 Day | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Probability Sample | ||||||
| Study Population | the patients wha has surgery continues more then 1 hour | ||||||
| Condition | Muscle Relaxation | ||||||
| Intervention | 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
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| Study Groups/Cohorts | Not Provided | ||||||
| Publications * | Not Provided | ||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||
| Recruitment Status | Completed | ||||||
| Actual Enrollment |
100 | ||||||
| Original Estimated Enrollment |
84 | ||||||
| Actual Study Completion Date | August 1, 2020 | ||||||
| Actual Primary Completion Date | March 1, 2020 (Final data collection date for primary outcome measure) | ||||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender |
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| Ages | 18 Years to 65 Years (Adult, Older Adult) | ||||||
| Accepts Healthy Volunteers | No | ||||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||||
| Listed Location Countries | Turkey | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT03926650 | ||||||
| Other Study ID Numbers | ErzincanUnv | ||||||
| Has Data Monitoring Committee | No | ||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Hakan Gokalp TAS, Erzincan University | ||||||
| Study Sponsor | Erzincan University | ||||||
| Collaborators | Not Provided | ||||||
| Investigators |
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| PRS Account | Erzincan University | ||||||
| Verification Date | April 2021 | ||||||
