UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038098 |
|---|---|
| Receipt number | R000039819 |
| Scientific Title | Optimal intrathecal hyperbaric bupivacaine dose with opioids for cesarean delivery |
| Date of disclosure of the study information | 2019/09/25 |
| Last modified on | 2020/11/09 17:06:30 |
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Basic information
Public title
Optimal intrathecal hyperbaric bupivacaine dose with opioids for cesarean delivery
Acronym
Optimal intrathecal hyperbaric bupivacaine dose with opioids for cesarean delivery
Scientific Title
Optimal intrathecal hyperbaric bupivacaine dose with opioids for cesarean delivery
Scientific Title:Acronym
Optimal intrathecal hyperbaric bupivacaine dose with opioids for cesarean delivery
Region
| Japan |
Condition
Condition
cesarean delivery
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We investigate the optimal dose of intrathecal hyperbaric bupivacaine, co-administered with opioids, for anesthesia for cesarean delivery.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
successful induction of spinal anesthesia
Key secondary outcomes
successful maintenance of spinal anesthesia
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
6
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
hyperbaric bupivacaine: 0.5%: 8 mg
Interventions/Control_2
hyperbaric bupivacaine: 0.5%: 9 mg
Interventions/Control_3
hyperbaric bupivacaine: 0.5%: 10 mg
Interventions/Control_4
hyperbaric bupivacaine: 0.5%: 11 mg
Interventions/Control_5
hyperbaric bupivacaine: 0.5%: 12 mg
Interventions/Control_6
hyperbaric bupivacaine: 0.5%: 13 mg
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| 99 | years-old | > |
Gender
Female
Key inclusion criteria
elective cesarean delivery, American Society of Anesthesiologists physical status class <3, age >=20 years, height 140-180 cm, singleton pregnancy, gestational age >=37 weeks
Key exclusion criteria
active labor, ruptured membranes, >=3 previous cesarean
deliveries, gestational diabetes, pregnancy-induced hypertension, intrauterine growth retardation, placenta previa or a body mass index >=35
Target sample size
34
Research contact person
Name of lead principal investigator
| 1st name | Ryo |
| Middle name | |
| Last name | Nishino |
Organization
Tohoku Kosai Hospital
Division name
Department of Anesthesiology
Zip code
9800803
Address
2-3-11, Kokubuncho, Aoba-ku, Sendai, Miyagi, Japan
TEL
0222272211
ryonishino@me.com
Public contact
Name of contact person
| 1st name | Ryo |
| Middle name | |
| Last name | Nishino |
Organization
Tohoku Kosai Hospital
Division name
Department of Anesthesiology
Zip code
9800803
Address
2-3-11, Kokubuncho, Aoba-ku, Sendai, Miyagi, Japan
TEL
0222272211
Homepage URL
ryonishino@me.com
Sponsor or person
Institute
Department of Anesthesiology, Tohoku Kosai Hospital
Institute
Department
Personal name
Funding Source
Organization
Tohoku Kosai Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Tohoku Kosai Hospital
Address
2-3-11, Kokubuncho, Aoba-ku, Sendai, Miyagi, Japan
Tel
0222272211
ryonishino@me.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
| 2019 | Year | 09 | 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
34
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
| 2018 | Year | 12 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 10 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 09 | Month | 25 | Day |
Last modified on
| 2020 | Year | 11 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039819
