UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effectiveness of prophylactic doses of intravenous nitroglycerin in preventing the incidence of myocardial ischemia under general anesthesia
Title of the study (Brief title)	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	Hiroshi Hoshijima
Organization	Saitama medical university hospital
Division name	Anesthesiology
Address	Saitama, Irumagunn, Moroyama, Morohongo38
TEL	049-276-1271
Email	hhoshi@saitama-med.ac.jp

Public contact
Name of contact person	Hiroshi Hoshijima
Organization	Saitama medical university hospital
Division name	Anesthesiology
Address	Saitama, Irumagunn, Moroyama, Morohongo38
TEL	049-276-1271
Homepage URL
Email	hhoshi@saitama-med.ac.jp

Sponsor
Institute	Saitama medical university hospital, Anesthsiology
Institute
Department

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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 04 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023157