Unique ID issued by UMIN | UMIN000038456 |
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Receipt number | R000043821 |
Scientific Title | Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia |
Date of disclosure of the study information | 2019/10/31 |
Last modified on | 2024/02/27 10:26:19 |
Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia
Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia
Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia
Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia
Japan |
Patients who undergo surgery under general anesthesia
Anesthesiology | Adult |
Others
NO
To determine the appropriate condition and elucidate the efficacy, safety and tolerability of transcutaneous vagus nerve stimulation during general anesthesia.
Safety,Efficacy
Parameters of heart rate variability measurements
Interventional
Parallel
Non-randomized
Double blind -all involved are blinded
Placebo
2
Treatment
Device,equipment |
Transcutaneous vagus nerve stimulation (5.0 mA)
Sham stimulation (0 mA)
20 | years-old | <= |
60 | years-old | > |
Male and Female
1. Patients scheduling to undergo elective surgery under general anesthesia
2. Patients of American Society of Anesthesiologists physical status 1
3. Patients scheduling to undergo low cardiac risk surgery
4. Patients of normal sinus rhythm in preoperative electrocardiogram
1. Patients schedules to undergo head and neck surgery
2. Patients with a history of vasovagal syncope
3. Patients with a history of arrhythmia
4. Patients with a history of surgery or trauma of the auricle, neck, chest or heart
5. Patients with injuries in the skin, subcutaneous tissue or muscle of the auricle or neck
6. Patients taking an antihypertensive, antiarrhythmic or psychotropic drug
7. Pregnant women or lactating women
8. Patients with a history of cerebral aneurysm treatment
9. Patients with implanted medical devices
40
1st name | Ryo |
Middle name | |
Last name | Wakabayashi |
Shinshu University School of Medicine
Department of Anesthesiology and Resuscitology
390-8621
3-1-1, Asahi, Matsumoto
+81-263-37-2670
waka0924@shinshu-u.ac.jp
1st name | Ryo |
Middle name | |
Last name | Wakabayashi |
Shinshu University School of Medicine
Department of Anesthesiology and Resuscitology
390-8621
3-1-1, Asahi, Matsumoto, Nagano
+81-263-37-2670
waka0924@shinshu-u.ac.jp
Shinshu University
Self funding
Self funding
Shinshu University School of Medicine, Institutional Review Board
3-1-1, Asahi, Matsumoto, Nagano
+81-263-37-2572
mdrinri@shinshu-u.ac.jp
NO
2019 | Year | 10 | Month | 31 | Day |
Unpublished
Completed
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 03 | Month | 14 | Day |
2019 | Year | 10 | Month | 31 | Day |
2024 | Year | 03 | Month | 04 | Day |
2019 | Year | 10 | Month | 31 | Day |
2024 | Year | 02 | Month | 27 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043821
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