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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030016
Receipt No. R000034270
Scientific Title Effect of ultra-low-dose naloxone on intrathecal opioid-induced respiratory depression in cesarean delivery: a double-center prospective controlled trial
Date of disclosure of the study information 2017/11/20
Last modified on 2018/09/10

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Basic information
Public title Effect of ultra-low-dose naloxone on intrathecal opioid-induced respiratory depression in cesarean delivery: a double-center prospective controlled trial
Acronym Effect of ultra-low-dose naloxone on opioid-induced respiratory depression
Scientific Title Effect of ultra-low-dose naloxone on intrathecal opioid-induced respiratory depression in cesarean delivery: a double-center prospective controlled trial
Scientific Title:Acronym Effect of ultra-low-dose naloxone on opioid-induced respiratory depression
Region
Japan

Condition
Condition Hypoxia
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This randomised prospective, controlled trial aimed to evaluate the effect of ultra-low-dose naloxone on the incidence of intrathecal opioids-induced respiratory depression.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The incidence of opioid-induced respiratory depression within the first 24hr after administration of intrathecal opioids.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 After delivery of the baby, the paitents are randomized to receive ultra-low-dose naloxone.
Interventions/Control_2 After delivery of the baby, the paitents are randomized to receive saline.
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 1) ASA physical status 2-3 ptients who presented for elective cesarean delivery under spinal anesthesia

2) Written informed consent is obtained from beach patients enrolled in the study.
Key exclusion criteria 1) Emergency cesarean delivery
2) Allergy to naloxone, pentazocine, morphine, fentanyl, bupivacaine or lebobupivacaine
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noritaka Imamachi
Organization Shimane University Faculty of Medicine
Division name Department of Anesthesiology
Zip code
Address 89-1 Enyacho Izumo, Shimane, Japan
TEL 0853-20-2295
Email imamachi@med.shimane-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noritaka Imamachi
Organization Shimane University Faculty of Medicine
Division name Department of Anesthesiology
Zip code
Address 89-1 Enyacho Izumo, Shimane, Japan
TEL 0853-20-2295
Homepage URL
Email imamachi@med.shimane-u.ac.jp

Sponsor
Institute Shimane University
Institute
Department

Funding Source
Organization Shimane University
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Anesthesiology, Hamada Medical Center
Name of secondary funder(s) None

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2017 Year 11 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 Completed
Date of protocol fixation
2017 Year 11 Month 08 Day
Date of IRB
Anticipated trial start date
2017 Year 11 Month 20 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 11 Month 17 Day
Last modified on
2018 Year 09 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034270

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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