UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030016 |
|---|---|
| Receipt number | 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 13:47:29 |
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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
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
imamachi@med.shimane-u.ac.jp
Sponsor or person
Institute
Shimane University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034270
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
