UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045845 |
|---|---|
| Receipt number | R000051296 |
| Scientific Title | Effectiveness of measuring salivary alpha-amylase activity to evaluate surgical stimulus in patients undergoing breast surgery |
| Date of disclosure of the study information | 2021/10/29 |
| Last modified on | 2021/10/24 23:00:11 |
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Basic information
Public title
Effectiveness of measuring salivary alpha-amylase activity to evaluate surgical stimulus and post operative pain in patients undergoing breast surgery
Acronym
Effectiveness of measuring salivary alpha-amylase activity to evaluate surgical stimulus and post operative pain
Scientific Title
Effectiveness of measuring salivary alpha-amylase activity to evaluate surgical stimulus in patients undergoing breast surgery
Scientific Title:Acronym
Effectiveness of measuring salivary alpha-amylase activity to evaluate surgical stimulus and post operative pain
Region
| Japan |
Condition
Condition
patients scheduled for breast surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Verification of that whether measurement of salivary alpha-amylase activity might be an evaluation method for surgical stimulus and post operative pain
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Values of salivary alpha-amylase activity before and after tracheal intubation under general anesthesia.
Key secondary outcomes
Relationship between intraoperative salivary alpha-amylase activity level and post operative analgesic consumption
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Single blind -participants are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
administration dose of fentanyl during anesthesia induction (1.0 mcg/kg)
Interventions/Control_2
administration dose of fentanyl during anesthesia induction (2.0 mcg/kg)
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
Key exclusion criteria
salivary secretion disorder
Target sample size
50
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
Nihon University Itabashi Hospital
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
sakatani.tsugiko@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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 10 | Month | 29 | Day |
Related information
URL releasing protocol
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-22792020/
Publication of results
Unpublished
Result
URL related to results and publications
https://kaken.nii.ac.jp/ja/grant/KAKENHI-PROJECT-22792020/
Number of participants that the trial has enrolled
50
Results
Salivary alpha-amylase activity was significantly decreased after induction of general anesthesia, and it turned to increase significantly after tracheal intubation. Additionally, the increase in salivary alpha-amylase activity was suppressed in dose dependent manner of fentanyl. These results suggested that increase in salivary alpha-amylase activity was associated with noxious stimulus level under general anesthesia.
Results date posted
| 2021 | Year | 10 | Month | 24 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Patients who were received elective breast surgery under general anesthesia
Participant flow
A total of 50 patients were recruited. The patients were randomly divided into 2 groups of 25 each according to the envelope method, with one group receiving 1.0 mcg/kg of fentanyl and one group receiving 2.0 mcg/kg of fentanyl during anesthesia induction. The data of patients who were treated with atropine during tracheal intubation maneuver, or who failed intubation at the first try were excluded.
Adverse events
none
Outcome measures
Change in salivary alpha-amylase activity before and after tracheal intubation under general anesthesia.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2011 | Year | 06 | Month | 03 | Day |
Date of IRB
| 2011 | Year | 06 | Month | 03 | Day |
Anticipated trial start date
| 2011 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 10 | Month | 24 | Day |
Last modified on
| 2021 | Year | 10 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051296
