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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019938
Receipt No. R000023025
Scientific Title The saving effect of nitrous oxide on a required dose of remifentanil during low flow sevoflurane anesthesia
Date of disclosure of the study information 2015/11/26
Last modified on 2015/11/26

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Basic information
Public title The saving effect of nitrous oxide on a required dose of remifentanil during low flow sevoflurane anesthesia
Acronym The saving effect of nitrous oxide
Scientific Title The saving effect of nitrous oxide on a required dose of remifentanil during low flow sevoflurane anesthesia
Scientific Title:Acronym The saving effect of nitrous oxide
Region
Japan

Condition
Condition Surgical patients
Classification by specialty
Anesthesiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The aim of current investigation was to evaluate the cost-saving effect of N2O during low flow general anesthesia.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The estimated cost.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Oxygen and air as fresh gas.
Interventions/Control_2 Oxygen and 70% nitrous oxide as fresh gas.
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
100 years-old >
Gender Male and Female
Key inclusion criteria General anesthesia.
Key exclusion criteria The case with severe complications.
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yushi Adachi
Organization Tokyo Medical and Dental University
Division name Department of Intensive Care Medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5959
Email yuadachi.ccm@tmd.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yushi Adachi
Organization Tokyo Medical and Dental University
Division name Department of Intensive Care Medicine
Zip code
Address 1-5-45 Yushima, Bunkyo-ku, Tokyo, Japan
TEL 03-5803-5959
Homepage URL
Email yuadachi.ccm@tmd.ac.jp

Sponsor
Institute Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization Tokyo Medical and Dental University
Organization
Division
Category of Funding Organization
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
2015 Year 11 Month 26 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
2015 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2016 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 11 Month 26 Day
Last modified on
2015 Year 11 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023025

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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