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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000034962
Receipt No. R000039862
Official scientific title of the study The investigation of the effects of sympathomimetic drugs in the patients with Parkinson's disease
Date of disclosure of the study information 2018/12/01
Last modified on 2018/11/21

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Basic information
Official scientific title of the study The investigation of the effects of sympathomimetic drugs in the patients with Parkinson's disease
Title of the study (Brief title) The investigation of the effects of sympathomimetic drugs in Parkinson's disease patients.
Region
Japan

Condition
Condition Parkinson's disease
Classification by specialty
Neurology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 There is some patients who have excessive response to sympathomimetic drugs due to cardiac sympathetic nerve denervation. In this study, we try to discribe the relation of autonimic tests and the incidence of denervation supersensitivity.
Basic objectives2 Others
Basic objectives -Others Based on the result, we fine indicators for the inccidence risk of denervation supersensitivity.
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The response for sympathomimetic drugs in blood pressure and heart rate.
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
18 years-old <=
Age-upper limit
90 years-old >
Gender Male and Female
Key inclusion criteria The patients with Parkinson's disease and sithout Parkinson's disease (for the control)


Surgical patients who are performed any operation under anesthesia in our hospital.
Key exclusion criteria Patients without concent
Patients without enough preoperative assessment.
Target sample size 348

Research contact person
Name of lead principal investigator Shinichi Nakao
Organization Kindai University Faculty of Medicine
Division name Anesthesiology
Address 377-2 Ono-Higashi,Osaka-Sayama,Osaka
TEL 0723660221
Email minminmin2121@yahoo.co.jp

Public contact
Name of contact person Atsuhiro Kitaura
Organization Kindai University Faculty of Medicine
Division name anesthegiology
Address 377-2 Ono-Higashi, Osaka-Sayama, Osaka
TEL 0723660221
Homepage URL
Email kitaura@med.kindai.ac.jp

Sponsor
Institute Kindai University Faculty of Medicine
Department of Anesthesiology
Institute
Department

Funding Source
Organization none
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization JP

Other related organizations
Co-sponsor
Name of secondary funder(s)

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 近畿大学医学部附属病院

Other administrative information
Date of disclosure of the study information
2018 Year 12 Month 01 Day

Progress
Recruitment status Preinitiation
Date of protocol fixation
2018 Year 07 Month 01 Day
Anticipated trial start date
2018 Year 12 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information none

Management information
Registered date
2018 Year 11 Month 21 Day
Last modified on
2018 Year 11 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039862

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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