UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050753 |
|---|---|
| Receipt number | R000057825 |
| Scientific Title | comparison of automatic and manual anesthesia for the prevention of postoperative cognitive dysfunction |
| Date of disclosure of the study information | 2023/04/03 |
| Last modified on | 2023/05/15 22:24:59 |
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Basic information
Public title
comparison of automatic and manual anesthesia for the prevention of postoperative cognitive dysfunction
Acronym
comparison of automatic and manual anesthesia for the prevention of postoperative cognitive dysfunction
Scientific Title
comparison of automatic and manual anesthesia for the prevention of postoperative cognitive dysfunction
Scientific Title:Acronym
comparison of automatic and manual anesthesia for the prevention of postoperative cognitive dysfunction
Region
| Japan |
Condition
Condition
patients undergoing orthopaedic surgery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the efficacy of automatic and manual anesthesia for prevention of postoperative cognitive dysfunction(POCD).
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
frequency of the postoperative cognitive dysfunction
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Autmated general anesthesia
Interventions/Control_2
Manual general anesthesia
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
American Society of Anesthesiologists physical status of I -II
Key exclusion criteria
American Society of Anesthesiologists(ASA) physical status of III-V
patients with mental disorders
Patients with neurological disorders
Patients on psychotic drugs
Patients without consent
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroki |
| Middle name | |
| Last name | Yonezawa |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
770-8503
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
TEL
0886337181
hiroki-yonezawa@tokushima-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroki |
| Middle name | |
| Last name | Yonezawa |
Organization
Tokushima University Hospital
Division name
Anesthesiology
Zip code
7700-8503
Address
2-50-1, Kuramoto-cho, Tokushima, Tokushima, Japan
TEL
0886337181
Homepage URL
hiroki-yonezawa@tokushima-u.ac.jp
Sponsor or person
Institute
Tokushima University Hospital
Institute
Department
Personal name
Funding Source
Organization
Tokushima University Hospital
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
Clinical Research Center for Developmental Therapeutics
Address
2-50-1 Kuramoto-cho, Tokushima City
Tel
088-633-8512
first-ec@tokushima-u.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
| 2023 | Year | 04 | Month | 03 | 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
| 2023 | Year | 05 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 04 | Month | 03 | Day |
Last modified on
| 2023 | Year | 05 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057825
