UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038456 |
|---|---|
| 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 |
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Basic information
Public title
Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia
Acronym
Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia
Scientific Title
Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia
Scientific Title:Acronym
Efficacy, safety and effects on depth of anesthesia of transcutaneous vagus nerve stimulation during general anesthesia
Region
| Japan |
Condition
Condition
Patients who undergo surgery under general anesthesia
Classification by specialty
| Anesthesiology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the appropriate condition and elucidate the efficacy, safety and tolerability of transcutaneous vagus nerve stimulation during general anesthesia.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Parameters of heart rate variability measurements
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Transcutaneous vagus nerve stimulation (5.0 mA)
Interventions/Control_2
Sham stimulation (0 mA)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Wakabayashi |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto
TEL
+81-263-37-2670
waka0924@shinshu-u.ac.jp
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Wakabayashi |
Organization
Shinshu University School of Medicine
Division name
Department of Anesthesiology and Resuscitology
Zip code
390-8621
Address
3-1-1, Asahi, Matsumoto, Nagano
TEL
+81-263-37-2670
Homepage URL
waka0924@shinshu-u.ac.jp
Sponsor or person
Institute
Shinshu University
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Shinshu University School of Medicine, Institutional Review Board
Address
3-1-1, Asahi, Matsumoto, Nagano
Tel
+81-263-37-2572
mdrinri@shinshu-u.ac.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 10 | Month | 31 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2019 | Year | 03 | Month | 14 | Day |
Date of IRB
| 2019 | Year | 03 | Month | 14 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 31 | Day |
Last follow-up date
| 2024 | Year | 03 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 31 | Day |
Last modified on
| 2024 | Year | 02 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043821
