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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010993
Receipt No. R000012867
Scientific Title Effect of continuous infusion of phenylephrine on maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section; prospective randomized control trial
Date of disclosure of the study information 2013/06/24
Last modified on 2014/12/18

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Basic information
Public title Effect of continuous infusion of phenylephrine on maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section; prospective randomized control trial
Acronym Effect of continuous infusion of phenylephrine on maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section
Scientific Title Effect of continuous infusion of phenylephrine on maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section; prospective randomized control trial
Scientific Title:Acronym Effect of continuous infusion of phenylephrine on maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section
Region
Japan

Condition
Condition Full term pregnancy
Classification by specialty
Obsterics and gynecology Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Suppressive effect of continuous infusion of phenylephrine on decrease in maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Change in maternal cerebral blood flow and oxygenation during spinal anesthesia for cesarean section evaluated by near infrared spectroscopy (NIRS)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Medicine Device,equipment
Interventions/Control_1 Continuous infusion of saline, at a rate of 1 ml/min, during 20 min after intrathecal injection of bupivacaine
Interventions/Control_2 Continuous infusion of phenylephrine, at a rate of 25 mcg/min, during 20 min after intrathecal injection of bupivacaine
Interventions/Control_3 Continuous infusion of phenylephrine, at a rate of 50 mcg/min, during 20 min after intrathecal injection of bupivacaine
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
18 years-old <=
Age-upper limit

Not applicable
Gender Female
Key inclusion criteria Healthy full-term pregnant woman aged over 18, undergoing elective cesarean section under spinal anesthesia
Key exclusion criteria Patient with a diagnosis of hypertension, diabetes and renal dysfunction due to pregnancy, and obese patient whose BMI >30
Target sample size 60

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Noriya Hirose
Organization Nihon University School of Medicine
Division name Division of Anesthesiology, Department of Anesthesiology
Zip code
Address 30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Email hirose.noriya@nihon-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Noriya Hirose
Organization Nihon University School of Medicine
Division name Division of Anesthesiology, Department of Anesthesiology
Zip code
Address 30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL 03-3972-8111
Homepage URL
Email hirose.noriya@nihon-u.ac.jp

Sponsor
Institute Nihon University School of Medicine
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
Address
Tel
Email

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
2013 Year 06 Month 24 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 Completed
Date of protocol fixation
2013 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 24 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 06 Month 18 Day
Last modified on
2014 Year 12 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012867

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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