UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054717 |
|---|---|
| Receipt number | R000062528 |
| Scientific Title | A retrospective study of drug dosage for single shot spinal subarachnoid anesthesia for cesarean section at Showa University Northern Yokohama Hospital |
| Date of disclosure of the study information | 2024/06/20 |
| Last modified on | 2024/06/20 10:57:25 |
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Basic information
Public title
A retrospective study of drug dosage for single shot spinal subarachnoid anesthesia for cesarean section at Showa University Northern Yokohama Hospital
Acronym
A retrospective study of drug dosage for single shot spinal subarachnoid anesthesia for cesarean section at Showa University Northern Yokohama Hospital
Scientific Title
A retrospective study of drug dosage for single shot spinal subarachnoid anesthesia for cesarean section at Showa University Northern Yokohama Hospital
Scientific Title:Acronym
A retrospective study of drug dosage for single shot spinal subarachnoid anesthesia for cesarean section at Showa University Northern Yokohama Hospital
Region
| Japan |
Condition
Condition
cesarean section
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effect of anesthesia in cesarean section patients managed with single shot spinal subarachnoid anesthesia at Showa University Northern Yokohama Hospital.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Effect of anesthesia (analgesia)
Key secondary outcomes
Maternal hypotension after spinal subarachnoid anesthesia
Postoperative use of adjuvant analgesics
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
| 20 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Female
Key inclusion criteria
Cesarean section cases managed with single shot spinal subarachnoid anesthesia at Showa University Northern Yokohama Hospital
Key exclusion criteria
Cases in which two or more spinal subarachnoid anesthetics were administered
combined spinal epidural anesthesia
Target sample size
1000
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
ayayamamura128@gmail.com
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Yamamura |
Organization
Showa University Northern Yokohama Hospital
Division name
Department of Anesthesiology
Zip code
224-8503
Address
35-1 Chigasaki Chuo, Tsuzuki-ku, Yokohama City, Kanagawa Prefecture
TEL
045-949-7000
Homepage URL
ayayamamura128@gmail.com
Sponsor or person
Institute
Showa University
Showa University Northern Yokohama Hospital
Institute
Department
Personal name
Funding Source
Organization
Showa University
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
Showa University Research Ethics Review Board
Address
1-5-8 Hatanodai, Shinagawa-ku, Tokyo
Tel
03-3784-8000
m-rinri@ofc.showa-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
| 2024 | Year | 06 | Month | 20 | 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
Open public recruiting
Date of protocol fixation
| 2024 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patient Background
Anesthesia Effects
Retrospective study using medical records
Management information
Registered date
| 2024 | Year | 06 | Month | 20 | Day |
Last modified on
| 2024 | Year | 06 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062528
