UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023791 |
|---|---|
| Receipt number | 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 11:29:33 |
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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 | Obstetrics 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
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
kan@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.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 | |
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| Registered date | File name |
