UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000021467 |
|---|---|
| Receipt number | R000023157 |
| Scientific Title | The effectiveness of prophylactic doses of intravenous nitroglycerin in preventing the incidence of myocardial ischemia under general anesthesia |
| Date of disclosure of the study information | 2016/03/14 |
| Last modified on | 2018/03/27 06:10:28 |
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Basic information
Public title
The effectiveness of prophylactic doses of intravenous nitroglycerin in preventing the incidence of myocardial ischemia under general anesthesia
Acronym
The effectiveness of prophylactic doses of intravenous nitroglycerin in preventing the incidence of myocardial ischemia under general anesthesia
Scientific Title
The effectiveness of prophylactic doses of intravenous nitroglycerin in preventing the incidence of myocardial ischemia under general anesthesia
Scientific Title:Acronym
The effectiveness of prophylactic doses of intravenous nitroglycerin in preventing the incidence of myocardial ischemia under general anesthesia
Region
| Japan |
Condition
Condition
myocardial ischemia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to evaluate whether prophylactic intravenous TNG can prevent the incidence of intraoperative myocardial ischemia for anesthesized patients. In addition, we also analyzed hemodynamic changes (heart rate [HR], mean blood pressure [MBP], and pulmonary capillary wedge pressure [PCWP]) from TNG in both pre and post anesthesia induction as an indicator of the decrease in preload.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
incidence of myocardial ischemia
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
This review included all randomized controlled trials investigating the incidence of MI associated with TNG compared with placebo in surgical patients.
Key exclusion criteria
We excluded observational studies and those published as an abstract.
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hoshijima |
Organization
Saitama medical university hospital
Division name
Anesthesiology
Zip code
Address
Saitama, Irumagunn, Moroyama, Morohongo38
TEL
049-276-1271
hhoshi@saitama-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Hoshijima |
Organization
Saitama medical university hospital
Division name
Anesthesiology
Zip code
Address
Saitama, Irumagunn, Moroyama, Morohongo38
TEL
049-276-1271
Homepage URL
hhoshi@saitama-med.ac.jp
Sponsor or person
Institute
Saitama medical university hospital, Anesthsiology
Institute
Department
Personal name
Funding Source
Organization
Saitama medical university hospital
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
| 2016 | Year | 03 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Published
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
| 2015 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 05 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study was to evaluate whether prophylactic intravenous TNG can prevent the incidence of intraoperative myocardial ischemia for anesthesized patients. In addition, we also analyzed hemodynamic changes (heart rate [HR], mean blood pressure [MBP], and pulmonary capillary wedge pressure [PCWP]) from TNG in both pre and post anesthesia induction as an indicator of the decrease in preload.
Management information
Registered date
| 2016 | Year | 03 | Month | 14 | Day |
Last modified on
| 2018 | Year | 03 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023157
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
