UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023692 |
|---|---|
| Receipt number | R000027284 |
| Scientific Title | Optimal dose of intrathecal hyperbaric bupivacaine with opioids for cesarean delivery:a prospective, randomized, double-blinded, dose-ranging study |
| Date of disclosure of the study information | 2016/08/22 |
| Last modified on | 2019/04/09 14:48:08 |
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Basic information
Public title
Optimal dose of intrathecal hyperbaric bupivacaine with opioids for cesarean delivery:a prospective, randomized, double-blinded, dose-ranging study
Acronym
Optimal dose of intrathecal hyperbaric bupivacaine with opioids for cesarean delivery
Scientific Title
Optimal dose of intrathecal hyperbaric bupivacaine with opioids for cesarean delivery:a prospective, randomized, double-blinded, dose-ranging study
Scientific Title:Acronym
Optimal dose of intrathecal hyperbaric bupivacaine with opioids for cesarean delivery
Region
| Japan |
Condition
Condition
Cesarean delivery
Classification by specialty
| Obstetrics and Gynecology | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Optimal dose of intrathecal hyperbaric bupivacaine in Cesarean delivery
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the optimal dose of hyperbaric bupivacaine co-administered with fentanyl and morphine for Cesarean delivery without supplemental analgesia
Key secondary outcomes
1. the cumulative dose of phenylephrine
2. frequency of adverse events
3. maternal satisfaction
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
YES
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
7
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
intrathecal 6mg hyperbaric bupivacaine co-administered with fentanyl 15 mcg and morphine 75 mcg
Interventions/Control_2
intrathecal 7mg hyperbaric bupivacaine co-administered with fentanyl 15 mcg and morphine 75 mcg
Interventions/Control_3
intrathecal 8mg hyperbaric bupivacaine co-administered with fentanyl 15 mcg and morphine 75 mcg
Interventions/Control_4
intrathecal 9mg hyperbaric bupivacaine co-administered with fentanyl 15 mcg and morphine 75 mcg
Interventions/Control_5
intrathecal 10mg hyperbaric bupivacaine co-administered with fentanyl 15 mcg and morphine 75 mcg
Interventions/Control_6
intrathecal 11mg hyperbaric bupivacaine co-administered with fentanyl 15 mcg and morphine 75 mcg
Interventions/Control_7
intrathecal 12mg hyperbaric bupivacaine co-administered with fentanyl 15 mcg and morphine 75 mcg
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Female
Key inclusion criteria
1. American Society Anesthesiologists physical status class I, or II
2. height between 140 and 180 cm
3. singleton pregnancy
4. gestational age of more 37 completed weeks
Key exclusion criteria
1. active labor
2. ruptured membranes
3. three or more previous Cesarean deliveries
4. gestational diabetes
5. pregnancy induced hypertension
6. intrauterine growth retardation
7. placenta previa
8. body mass index more than 35
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Mamoru |
| Middle name | |
| Last name | Murakami |
Organization
Tohoku Kosai Hospital
Division name
Department of anesthesiology
Zip code
9800803
Address
2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
TEL
+08-22-227-2211
masuiker@gmail.com
Public contact
Name of contact person
| 1st name | Eiko |
| Middle name | |
| Last name | Onishi |
Organization
Took University Hospital
Division name
Department of anesthesiology
Zip code
9808574
Address
1-1 Seiryo-machi, Aoba-ku, Sendai, Miyagi, Japan
TEL
+08-22-717-7321
Homepage URL
e-onishi@med.tohoku.ac.jp
Sponsor or person
Institute
Tohoku Kosai Hospital, Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
None
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 Institutional Review Board
Address
2-3-11, Kokubuncho, Aobaku, Sendai, Miyagi, Japan
Tel
+08-22-227-2211
syomu01@tohokukosai.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
Tohoku Kosai Hospital (Miyagi)
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 22 | Day |
Related information
URL releasing protocol
https://www.sciencedirect.com/science/article/pii/S0959289X16301820?via%3Dihub
Publication of results
Published
Result
URL related to results and publications
https://www.sciencedirect.com/science/article/pii/S0959289X16301820?via%3Dihub
Number of participants that the trial has enrolled
70
Results
The ED95 for success (main) was 12.6mg. The incidence of respiratory discomfort and maternal satisfaction scores did not differ significantly between dose groups. Phenylephrine dose and nausea/vomiting incidence increased with increasing doses of bupivacaine.
Results date posted
| 2019 | Year | 04 | Month | 09 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Healthy, term parturients who were scheduled for elective cesarean delivery were enrolled.
Participant flow
Patients were randomized, according to a computer-generated randomization list using sealed opaque envelopes, into seven groups. The patient and assessing investigator were blinded to group allocation. On the day of surgery the envelope was handed to an anesthesiologist not involved in the study who prepared the study medications. The study medication was given to the blinded anesthesiologist having charge of perioperative anesthetic management before induction of anesthesia.
Adverse events
none
Outcome measures
Effective doses for 50% (ED50) and 95% (ED95) of subjects required for successmain during cesarean delivery.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2010 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2010 | Year | 04 | Month | 05 | Day |
Anticipated trial start date
| 2010 | Year | 05 | Month | 26 | Day |
Last follow-up date
| 2016 | Year | 12 | 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
| 2016 | Year | 08 | Month | 19 | Day |
Last modified on
| 2019 | Year | 04 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027284
