UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000043780 |
|---|---|
| Receipt number | R000049976 |
| Scientific Title | Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty with remimazolam. |
| Date of disclosure of the study information | 2021/04/01 |
| Last modified on | 2022/03/30 09:24:44 |
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Basic information
Public title
Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty with remimazolam.
Acronym
Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty with remimazolam.
Scientific Title
Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty with remimazolam.
Scientific Title:Acronym
Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty with remimazolam.
Region
| Japan |
Condition
Condition
Balloon Kyphoplasty
Classification by specialty
| Orthopedics | Anesthesiology | Operative medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Incidence of postoperative cognitive dysfunction in elderly patient after Balloon Kyphoplasty with remimazolam
Basic objectives2
Others
Basic objectives -Others
Incidence of postoperative cognitive dysfunction
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Incidence of postoperative cognitive dysfunction
Key secondary outcomes
Incidence of delirium
Length of hospital stay
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)ASA class 1 or 2
2)Elective surgery
3)A person with written voluntary informed consent based on the comprehensive explanation and understanding before joining this study
Key exclusion criteria
1)Patients who can not carry out some cognitive function tests before a surgical operation
2)Patients who are inappropriate for this study by physician
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yuka |
| Middle name | |
| Last name | Sato |
Organization
Omagari Kosei Medical Center
Division name
Department of Anesthesia
Zip code
014-0027
Address
8-65 Omagari-Torimachi, Daisen, Akita, Japan
TEL
+81-187-6-32111
yukabon0719@gmail.com
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | Sato |
Organization
Omagari Kosei Medical Center
Division name
Department of Anesthesia
Zip code
014-0027
Address
8-65 Omagari-Torimachi, Daisen, Akita, Japan
TEL
+81-187-6-32111
Homepage URL
yukabon0719@gmail.com
Sponsor or person
Institute
Department of Anesthesia, Omagari Kosei Medical Center
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesia, Omagari Kosei Medical Center
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
Omagari Kosei Medical Center
Address
8-65 Omagari-Torimachi, Daisen, Akita, Japan
Tel
+81-187-63-2111
yukabon0719@gmail.com
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 | 03 | Month | 31 | Day |
Date of IRB
| 2021 | Year | 03 | Month | 25 | Day |
Anticipated trial start date
| 2021 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2022 | Year | 01 | Month | 01 | Day |
Other
Other related information
None
Management information
Registered date
| 2021 | Year | 03 | Month | 29 | Day |
Last modified on
| 2022 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049976
