UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041337 |
|---|---|
| Receipt number | R000047150 |
| Scientific Title | Incidence of respiratory depression associated with administration of intrathecal opioid for cesarean delivery: A randomized controlled trial. |
| Date of disclosure of the study information | 2020/08/07 |
| Last modified on | 2020/12/16 18:09:49 |
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Basic information
Public title
Incidence of respiratory depression associated with administration of intrathecal morphine for cesarean delivery
Acronym
Respiratory depression associated with administration of intrathecal morphine for cesarean delivery
Scientific Title
Incidence of respiratory depression associated with administration of intrathecal opioid for cesarean delivery: A randomized controlled trial.
Scientific Title:Acronym
Respiratory depression associated with administration of intrathecal opioid for cesarean delivery
Region
| Japan |
Condition
Condition
cesarean delivery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate respiratory depression induced by intrathecal opioid for cesarean delivery.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To evaluate hypoxia events after cesarean delivery.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Medicine |
Interventions/Control_1
Intrathecal morphine 50 microgram
Interventions/Control_2
Intrathecal morphine 100 microgram
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
| 45 | years-old | >= |
Gender
Female
Key inclusion criteria
1. Patients with elective cesarean delivery
under spinal anesthesia
2. American Society of Anesthesiologists
physical status: 2-3
3. The patient is over 20 years old.
4. Obtaining consent form from patients
Key exclusion criteria
1 Emergency surgery
2 Patients with allergy including
fentanyl, morphine and local anesthetic
3 Patient who already have respiratory complications
4 Patients with obesity (BMI>30)
5 Patients with sleep apnea syndrome
6 Patients with hypertension
7 Patients who have been using opioids
for a long time
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Kushizaki |
Organization
National Hospital Organization Hamada
Medical Center
Division name
Department of Anesthesiology
Zip code
697-8511
Address
777-12 Asaicho Hamada, Shimane
TEL
0855-25-0505
kushizaki.hiroyuki.mw@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Noritaka |
| Middle name | |
| Last name | Imamachi |
Organization
Shimane University
Division name
Department of Anesthesiology
Zip code
693-8501
Address
89-1 Enyacho Izumo, Shimane
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
Shimane University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The National Hospital Organization Hamada Medical Center Institutional Committee on Ethics
Address
777-12 Asaicho Hamada, Shimane
Tel
0855-25-0505
None
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
| 2020 | Year | 08 | Month | 07 | 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
Terminated
Date of protocol fixation
| 2020 | Year | 06 | Month | 19 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 19 | Day |
Anticipated trial start date
| 2020 | Year | 08 | Month | 03 | Day |
Last follow-up date
| 2022 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 08 | Month | 06 | Day |
Last modified on
| 2020 | Year | 12 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047150
