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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000023791
Receipt No. R000027411
Scientific Title Effects of inhaled anesthetics for postoperative sedation
Date of disclosure of the study information 2016/10/01
Last modified on 2017/02/26

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Basic information
Public title Effects of inhaled anesthetics for postoperative sedation
Acronym Postoperative sedation with inhaled anesthetics
Scientific Title Effects of inhaled anesthetics for postoperative sedation
Scientific Title:Acronym Postoperative sedation with inhaled anesthetics
Region
Japan

Condition
Condition Postoperative
Classification by specialty
Surgery in general Gastrointestinal surgery Hepato-biliary-pancreatic surgery
Vascular surgery Chest surgery Endocrine surgery
Breast surgery Obsterics and gynecology Dermatology
Oto-rhino-laryngology Orthopedics Urology
Anesthesiology Oral surgery Neurosurgery
Cardiovascular surgery Plastic surgery Aesthetic surgery
Operative medicine Emergency medicine Intensive care medicine
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to evaluate of efficacy and safety of inhaled anesthetics, sevoflurane during postoperative sedation as compared with intravenous anesthetics, propofol.
Basic objectives2 Others
Basic objectives -Others Organ function, Supressive effects of stress
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Extubation time
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Numbered container method

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Before surgery, the method of general anesthesia (inhaled anesthesia / TIVA)is decided. For inhaled anesthesia group, inhaled anesthetics will be administered postoperation.
Interventions/Control_2 Before surgery, the method of general anesthesia (inhaled anesthesia / TIVA)is decided. For TIVA group, propofol will be administered postoperation.
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

Not applicable
Gender Male and Female
Key inclusion criteria Postoperative patients who require mechanical ventilation in the ICU
Key exclusion criteria In case of risk of the patients will be increased by the study or the data cannnot be obtained.
Target sample size 130

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirotoshi Kitagawa
Organization Shiga University of Medical Science
Division name Department of Anesthesiology
Zip code
Address Seta-Tsukinowa, Otsu, Shiga
TEL 077-548-2281
Email hirotosi@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kan Takahashi
Organization Shiga University of Medical Science
Division name Department of Anesthesiology
Zip code
Address Seta-Tsukinowa, Otsu, Shiga
TEL 077-548-2281
Homepage URL
Email kan@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical Science
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
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
2016 Year 10 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 Terminated
Date of protocol fixation
2016 Year 05 Month 20 Day
Date of IRB
Anticipated trial start date
2016 Year 10 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

Management information
Registered date
2016 Year 08 Month 27 Day
Last modified on
2017 Year 02 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027411

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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