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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000043730
Receipt No. R000049932
Scientific Title Identification of factors inducing transient bradycardia during infiltration anesthesia
Date of disclosure of the study information 2021/04/01
Last modified on 2021/03/25

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Basic information
Public title Identification of factors inducing transient bradycardia during infiltration anesthesia
Acronym Identification of factors inducing transient bradycardia during infiltration anesthesia
Scientific Title Identification of factors inducing transient bradycardia during infiltration anesthesia
Scientific Title:Acronym Identification of factors inducing transient bradycardia during infiltration anesthesia
Region
Japan

Condition
Condition transient bradycardia
Classification by specialty
Anesthesiology Dental medicine Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To find factors that induce the transient occurrence of bradycardia during infiltration anesthesia.
Basic objectives2 Others
Basic objectives -Others to evaluate the efficacy of bradycardia inducing factors
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Efficacy of factors inducing transient bradycardia during infiltration anesthesia
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Other
Interventions/Control_1 Questionnaires and psychological examinations are performed at the pre-anesthetic consultation
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
65 years-old >
Gender Male and Female
Key inclusion criteria Patients who were recorded transient bradycardia during infiltration anesthesia in previous anesthesia records
Key exclusion criteria Patients with artificial pacemakers or using catecholamines or cardioactive drugs
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Ryo
Middle name
Last name Wakita
Organization Tokyo Medical and Dental University
Division name Dental Anesthesiology and Orofacial Pain Management
Zip code 113-8549
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 0358035549
Email ryoanph@tmd.ac.jp

Public contact
Name of contact person
1st name Wakita
Middle name
Last name Ryo
Organization Tokyo Medical and Dental University
Division name Dental Anesthesiology and Orofacial Pain Management
Zip code 113-8549
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
TEL 0358035549
Homepage URL
Email ryoanph@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
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 the Ethics Committee of Tokyo Medical and Dental University
Address 1-5-45, Yushima, Bunkyo-ku, Tokyo
Tel 0358035404
Email d-hyoka.adm@cmn.tmd.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 04 Month 01 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 Preinitiation
Date of protocol fixation
2021 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date
2021 Year 04 Month 05 Day
Last follow-up date
2023 Year 03 Month 31 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 03 Month 25 Day
Last modified on
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049932

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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