UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000022054 |
|---|---|
| Receipt number | R000025414 |
| Scientific Title | The observational study of the incidence of respiratory depression induced by intrathecal or epidural morphine in Cesarean section |
| Date of disclosure of the study information | 2016/04/25 |
| Last modified on | 2019/10/31 11:26:27 |
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Basic information
Public title
The observational study of the incidence of respiratory depression induced by intrathecal or epidural morphine in Cesarean section
Acronym
The respiratory depression of intrathecal or epidural morphine
Scientific Title
The observational study of the incidence of respiratory depression induced by intrathecal or epidural morphine in Cesarean section
Scientific Title:Acronym
The respiratory depression of intrathecal or epidural morphine
Region
| Japan |
Condition
Condition
status after Cesarean section
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the incidence of respiratory depression induced by intrathecal or epidural morphine in Cesarean section
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
the incidence of respiratory depression from just after operation to 9 am postoperative day 1
Key secondary outcomes
the problem and adverse event of this device
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
post-cesarean patient administered intrathecal or epidural morphine
Key exclusion criteria
Off-label use for intrathecal and epidural anesthesia
contraindication of morphine administeration
patient who managed by respirator
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shingo |
| Middle name | |
| Last name | Irikoma |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Anesthesiology
Zip code
43008558
Address
2-12-12, Sumiyoshi, Naka-ku, Hamamatsu City
TEL
053-474-2222
s.irikoma@gmail.com
Public contact
Name of contact person
| 1st name | Shingo |
| Middle name | |
| Last name | Irikoma |
Organization
Seirei Hamamatsu General Hospital
Division name
Department of Anesthesiology
Zip code
4308558
Address
2-12-12, Sumiyoshi, Naka-ku, Hamamatsu City
TEL
053-474-2222
Homepage URL
s.irikoma@gmail.com
Sponsor or person
Institute
Seirei Hamamatsu General Hospital
Institute
Department
Personal name
Funding Source
Organization
Nothing
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
National Center for Child Health and Development
Name of secondary funder(s)
IRB Contact (For public release)
Organization
IRB in Seirei Hamamatsu General Hospital
Address
2-12-12, Sumiyoshi, Naka-ku, Hamamatsu City
Tel
0534742222
s.irikoma@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
| 2016 | Year | 04 | Month | 25 | 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
| 2015 | Year | 10 | Month | 29 | Day |
Date of IRB
| 2016 | Year | 04 | Month | 25 | Day |
Anticipated trial start date
| 2016 | Year | 04 | Month | 25 | Day |
Last follow-up date
| 2019 | Year | 04 | Month | 25 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2017 | Year | 08 | Month | 31 | Day |
Other
Other related information
We will write a scientific article as soon as possible after finishing this study.
Management information
Registered date
| 2016 | Year | 04 | Month | 25 | Day |
Last modified on
| 2019 | Year | 10 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025414
