UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001553 |
|---|---|
| Receipt number | 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 12:27:57 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Department of Anestheiology and Intensive Care
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001876
