UMIN-CTR Clinical Trial

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
Email	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
Email	ryonishino@me.com

Sponsor
Institute	Department of Anesthesiology, Tohoku Kosai Hospital
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039819