UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014631 |
|---|---|
| Receipt number | R000017024 |
| Scientific Title | A study of the impact of spinal anesthesia on postoperative cognitive dysfunction |
| Date of disclosure of the study information | 2014/07/24 |
| Last modified on | 2017/02/16 21:35:21 |
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Basic information
Public title
A study of the impact of spinal anesthesia on postoperative cognitive dysfunction
Acronym
A study of the impact of spinal anesthesia on POCD
Scientific Title
A study of the impact of spinal anesthesia on postoperative cognitive dysfunction
Scientific Title:Acronym
A study of the impact of spinal anesthesia on POCD
Region
| Japan |
Condition
Condition
Patients undergoing surgery during spinal anesthesia aged over 65
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the impact of the spinal anesthesia on the cognitive disfunction in elderly patient
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Comparison of preoperative and postoperative cognitive function, using the postoperative quality of recovery scale: PQRS
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients whose American Society of Anesthesiologists Physical Status are 1 - 3, planned to surgery during spinal anesthesia are enrolled in this study.
Key exclusion criteria
Exclude criteria are the patients who have history of local anesthetic allergy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Rie Yasumura |
Organization
National hospital organization Tokyo medical center
Division name
Anesthesiology
Zip code
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
ryasumur@ntmc.hosp.go.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Rie Yasumura |
Organization
National hospital organization Tokyo medical center
Division name
Anesthesiology
Zip code
Address
2-5-1, Higashigaoka, Meguro-ku, Tokyo
TEL
03-3411-0111
Homepage URL
ryasumur@ntmc.hosp.go.jp
Sponsor or person
Institute
National hospital organization Tokyo medical center
Institute
Department
Personal name
Funding Source
Organization
Health and Labor Sciences Research Grant
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 07 | Month | 24 | 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
Completed
Date of protocol fixation
| 2014 | Year | 06 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 07 | Month | 24 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
postoperative quality of recovery scale
Management information
Registered date
| 2014 | Year | 07 | Month | 24 | Day |
Last modified on
| 2017 | Year | 02 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017024
