UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Phenylephrine infusion for prevention of hypotension during spinal anesthesia for elective cesarean section
Title of the study (Brief title)	Phenylephrine Infusion for Prevention of hypotension during spinal anesthesia for elective cesarean section
Region	Japan

Condition
Condition	elective cesarean section
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	prevention of hypotension
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	incidence of hypotension during elective cesarean section under spinal anesthesia
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Female
Key inclusion criteria	patients for elective cesarean section under spinal anesthesia
Key exclusion criteria	patients who can not communicate
Target sample size	40

Research contact person
Name of lead principal investigator	Daiki Nakashima
Organization	Gifu University Hospital
Division name	Department of Anesthesiology and Pain Medicine
Address	Gifu Yanagido 1-1
TEL	0582306000
Email	isi_m2001046@yahoo.co.jp

Public contact
Name of contact person	Daiki Nakashima
Organization	Gifu University Hospital
Division name	Department of Anesthesiology and Pain Medicine
Address	Gifu Yanagido 1-1
TEL	0582306000
Homepage URL
Email	isi_m2001046@yahoo.co.jp

Sponsor
Institute	Gifu University
Institute
Department

Funding Source
Organization	Gifu University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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	2018 Year 02 Month 24 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2018 Year 02 Month 14 Day
Anticipated trial start date	2018 Year 02 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Preinitiation

Management information
Registered date	2018 Year 02 Month 21 Day
Last modified on	2019 Year 01 Month 18 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000035864