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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000023692
Receipt No. 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

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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
Obsterics 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
Email 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
Email e-onishi@med.tohoku.ac.jp

Sponsor
Institute Tohoku Kosai Hospital, Department of Anesthesiology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027284

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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