UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000047392 |
|---|---|
| Receipt number | R000053420 |
| Scientific Title | Change in salivary alpha-amylase activity around precordial skin incision under general anesthesia |
| Date of disclosure of the study information | 2022/04/05 |
| Last modified on | 2023/04/09 14:13:18 |
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Basic information
Public title
change in salivary alpha-amylase activity around precordial skin incision under general anesthesia
Acronym
Change in salivary alpha-amylase activity due to surgical stimuli
Scientific Title
Change in salivary alpha-amylase activity around precordial skin incision under general anesthesia
Scientific Title:Acronym
Change in salivary alpha-amylase activity due to surgical stimuli
Region
| Japan |
Condition
Condition
Patients undergoing breast surgery under general anesthesia
Classification by specialty
| Breast surgery | Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
We investigate whether measurements of salivary alpha-amylase activity might be an ancillary method to assess the surgical stimuli under general anesthesia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in salivary alpha-amylase activity around precordial skin incision under general anesthesia
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 80 | years-old | >= |
Gender
Female
Key inclusion criteria
American Society of Anesthesiologists (ASA) physical status 1 or 2
Key exclusion criteria
Salivation abnormality
Autonomic nervous disorder
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Noriya |
| Middle name | |
| Last name | Hirose |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
173-8610
Address
Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan.
TEL
0339728111
hirose.noriya@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | Noriya |
| Middle name | |
| Last name | Hirose |
Organization
Nihon University School of Medicine
Division name
Department of Anesthesiology
Zip code
173-8610
Address
Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan.
TEL
0339728111
Homepage URL
hirose.noriya@nihon-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Nihon University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Nihon University School of Medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Hospital Ethics Committee on Human Rights in Clinical Trials and Research of Nihon University Itabashi Hospital
Address
Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan.
Tel
0339728111
komoda.nozomi@nihon-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
日本大学医学部附属板橋病院
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 04 | Month | 05 | 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
26
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
| 2022 | Year | 02 | Month | 02 | Day |
Date of IRB
| 2022 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2022 | Year | 04 | Month | 11 | Day |
Last follow-up date
| 2022 | Year | 11 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 05 | Month | 31 | Day |
Other
Other related information
Not applicable
Management information
Registered date
| 2022 | Year | 04 | Month | 04 | Day |
Last modified on
| 2023 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053420
