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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001553
Receipt No. R000001876
Scientific Title ECG changes associated with intra-operative tachycardia in patients undergoing a cesarean section and the effect of a short-acting beta blocker.
Date of disclosure of the study information 2011/04/01
Last modified on 2018/11/21

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Basic information
Public title ECG changes associated with intra-operative tachycardia in patients undergoing a cesarean section and the effect of a short-acting beta blocker.
Acronym The effect of a beta-blocker on tachycardia that develops during cesarean section.
Scientific Title ECG changes associated with intra-operative tachycardia in patients undergoing a cesarean section and the effect of a short-acting beta blocker.
Scientific Title:Acronym 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
1st name
Middle name
Last name Aya Nakae
Organization Osaka University Graduate School of Medicine
Division name Department of Anestheiology and Intensive Care
Zip code
Address 2-2 Yamadaoka Suita
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Medicine
Division name Department of Anestheiology and Intensive Care
Zip code
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)

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
2011 Year 04 Month 01 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
2008 Year 12 Month 05 Day
Date of IRB
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

Other
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

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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