UMIN-CTR Clinical Trial

Basic information
Public title	Comparison of hemodynamic responses to administration of vasopressin and norepinephrine under general anesthesia: a systematic review and meta-analysis of randomized control trials
Acronym	Comparison of hemodynamic responses to administration of vasopressin and norepinephrine under general anesthesia
Scientific Title	Comparison of hemodynamic responses to administration of vasopressin and norepinephrine under general anesthesia: a systematic review and meta-analysis of randomized control trials
Scientific Title:Acronym	Comparison of hemodynamic responses to administration of vasopressin and norepinephrine under general anesthesia
Region	Japan

Condition
Condition	Surgical patients with tracheal intubation
Classification by specialty	Anesthesiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to examine heart rate (HR), mean blood pressure (MBP), and central venous pressure (CVP) to determine whether vasopressin superior to norepinephrine for the hemodynamic responses.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	heart rate (HR), mean blood pressure (MBP), and central venous pressure (CVP)
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	Our search encompassed all trials that compared the measures associated with hemodynamic changes of heart rate (HR), mean blood pressure (MBP), and central venous pressure (CVP) between vasopressin and norepinephrine during general anesthesia.
Key exclusion criteria	pediatrics, ICU patients
Target sample size	150

Research contact person
Name of lead principal investigator	1st name Hiroshi Middle name Last name Hiroshi Hoshijima
Organization	Saitama Medical University Hospital
Division name	Anesthesiology
Zip code	350-0495
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL	0492761271
Email	hhoshi6@gmail.com

Public contact
Name of contact person	1st name Hiroshi Middle name Last name Hoshijima
Organization	Saitama Medical University Hospital
Division name	Anesthesiology
Zip code	350-0495
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
TEL	0492761271
Homepage URL
Email	hhoshi6@gmail.com

Sponsor
Institute	Saitama Medical University Hospital
Institute
Department

Funding Source
Organization	Saitama Medical University Hospital
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Saitama Medical University Hospital
Address	38 Morohongo, Moroyama-machi, Iruma-gun, Saitama, 350-0495, Japan
Tel	0492761271
Email	hhoshi6@gmail.com

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	2020 Year 01 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	Main results already published
Date of protocol fixation	2019 Year 03 Month 04 Day
Date of IRB	2018 Year 04 Month 07 Day
Anticipated trial start date	2019 Year 03 Month 04 Day
Last follow-up date	2020 Year 01 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information	We conducted a comprehensive search of the literature using PubMed, the Cochrane Central Register of Controlled Trials, EMBASE, and Scopus.

Management information
Registered date	2019 Year 03 Month 05 Day
Last modified on	2020 Year 10 Month 27 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000041115