UMIN-CTR Clinical Trial

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
Email	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
Email	hirose.noriya@nihon-u.ac.jp

Sponsor
Institute	Nihon University Itabashi Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051296