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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000009410
Receipt No. R000011057
Scientific Title Influence of antidepressants to hemodynamics during general anesthesia
Date of disclosure of the study information 2012/11/30
Last modified on 2012/11/27

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Basic information
Public title Influence of antidepressants to hemodynamics during general anesthesia
Acronym Antidepressants and anesthesia
Scientific Title Influence of antidepressants to hemodynamics during general anesthesia
Scientific Title:Acronym Antidepressants and anesthesia
Region
Japan

Condition
Condition Disease required surgery under general anesthesia
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the impact of various antidepressants to hemodynamics during general anesthesia
Basic objectives2 Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Do antidepressants affect to hemodynamics during general anesthesia ?
Which kind of antidepressants have a strong effect ?
Key secondary outcomes

Base
Study type Observational

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
15 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patients taking antidepressants
Key exclusion criteria 1. Preoperative general condition and operative procedure can significantly affect hemodynamics.
2. Combination with epidural anesthesia.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name FUTOSHI KIMURA
Organization Hirosaki university school of medicine
Division name Department of anesthesiology
Zip code
Address 5 Zaifucho Hirosaki Aomori Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Hirosaki university school of medicine
Division name Department of anesthesiology
Zip code
Address 5 Zaifucho Hirosaki Aomori Japan
TEL
Homepage URL
Email

Sponsor
Institute Department of anesthesiology, Hirosaki university school of medicine
Institute
Department

Funding Source
Organization Department of anesthesiology, Hirosaki university school of medicine
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
2012 Year 11 Month 30 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2008 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 01 Month 01 Day
Last follow-up date
2015 Year 12 Month 31 Day
Date of closure to data entry
2015 Year 12 Month 31 Day
Date trial data considered complete
2015 Year 12 Month 31 Day
Date analysis concluded
2016 Year 03 Month 31 Day

Other
Other related information 1. For patients who had been administered antidepressants before surgery, to examine the presence of vasopressors and their effects during general anesthesia.
2. To study differences due to the type of antidepressant.

Management information
Registered date
2012 Year 11 Month 27 Day
Last modified on
2012 Year 11 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011057

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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