UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	ECG changes associated with intra-operative tachycardia in patients undergoing a cesarean section and the effect of a short-acting beta blocker.
Title of the study (Brief title)	The effect of a beta-blocker on tachycardia that develops during cesarean section.
Region	Japan

Condition
Condition	patients undergoing a cesarean section
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	ST depression occurs in association with tachycardia in some patients undergoing a cesarean section;but the pathological significance or the frequency of this deveolpment is not known.The patients were divided into two groups for the present study, which was conducted to elucidate the significance and frequency of this ST depression, as well as the effect of a short-acting beta-blocker for such a condition.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Verify whether or not ECG changes can be supressed by preventing an increase in heart rate.
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -participants are blinded
Control	No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	For those patients whose their heart rates exceeding 100, continuous infusion of a short-acting beta-blocker was started to maintain their heart rate below 90.
Interventions/Control_2	For those patients develops ECG change at a heart rate below 100,sustained infusion of a beta blocker was started so that their heart rate associated with ECG change may be kept below 90% of that when changes had occurred.
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	60 years-old >=
Gender	Female
Key inclusion criteria	The participants of this study are those patients who submitted a written informed consent after sufficient information had been given.
Key exclusion criteria	Patients who have a history of hypersensitivity to short-acting beta-blockers.
Target sample size	100

Research contact person
Name of lead principal investigator	Aya Nakae
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anestheiology and Intensive Care
Address	2-2 Yamadaoka Suita
TEL
Email

Public contact
Name of contact person
Organization	Osaka University Graduate School of Medicine
Division name	Department of Anestheiology and Intensive Care
Address	2-2 Yamadaoka Suita
TEL
Homepage URL
Email

Sponsor
Institute	Osaka University Graduate School of Medicine Department of Anestheiology and Intensive Care
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)

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	2011 Year 04 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2008 Year 12 Month 05 Day
Anticipated trial start date	2009 Year 04 Month 01 Day
Last follow-up date	2011 Year 03 Month 01 Day
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

Management information
Registered date	2008 Year 12 Month 05 Day
Last modified on	2018 Year 11 Month 21 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001876