UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034962 |
|---|---|
| Receipt number | R000039862 |
| Scientific Title | 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 | 2023/03/21 23:58:00 |
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Basic information
Public title
The investigation of the effects of sympathomimetic drugs in the patients with Parkinson's disease
Acronym
The investigation of the effects of sympathomimetic drugs in Parkinson's disease patients.
Scientific Title
The investigation of the effects of sympathomimetic drugs in the patients with Parkinson's disease
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Shinichi Nakao |
Organization
Kindai University Faculty of Medicine
Division name
Anesthesiology
Zip code
Address
377-2 Ono-Higashi,Osaka-Sayama,Osaka
TEL
0723660221
minminmin2121@yahoo.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsuhiro Kitaura |
Organization
Kindai University Faculty of Medicine
Division name
anesthegiology
Zip code
Address
377-2 Ono-Higashi, Osaka-Sayama, Osaka
TEL
0723660221
Homepage URL
kitaura@med.kindai.ac.jp
Sponsor or person
Institute
Kindai University Faculty of Medicine
Department of Anesthesiology
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
Enrolling by invitation
Date of protocol fixation
| 2018 | Year | 07 | Month | 01 | Day |
Date of IRB
| 2018 | Year | 08 | Month | 08 | Day |
Anticipated trial start date
| 2018 | Year | 12 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Retrospective pilot reseach was started
Management information
Registered date
| 2018 | Year | 11 | Month | 21 | Day |
Last modified on
| 2023 | Year | 03 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039862
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