UMIN-CTR Clinical Trial

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
Email	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
Email	s.irikoma@gmail.com

Sponsor
Institute	Seirei Hamamatsu General Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000025414