UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017287 |
|---|---|
| Receipt number | R000020010 |
| Scientific Title | the examination of optimal dose of dexmedetomidine evaluated by respiratory rate and sedation degree for sedation under local anesthesia |
| Date of disclosure of the study information | 2015/04/28 |
| Last modified on | 2017/10/30 08:05:01 |
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Basic information
Public title
the examination of optimal dose of dexmedetomidine evaluated by respiratory rate and sedation degree for sedation under local anesthesia
Acronym
the examination of optimal dose of dexmedetomidine evaluated by respiratory rate and sedation degree for sedation under local anesthesia
Scientific Title
the examination of optimal dose of dexmedetomidine evaluated by respiratory rate and sedation degree for sedation under local anesthesia
Scientific Title:Acronym
the examination of optimal dose of dexmedetomidine evaluated by respiratory rate and sedation degree for sedation under local anesthesia
Region
| Japan |
Condition
Condition
Patients whom scheduled surgery in general, obsterics and gynecology, urology, orthopedics and plastic surgery
Classification by specialty
| Surgery in general | Obstetrics and Gynecology | Orthopedics |
| Urology | Plastic surgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
It is difficult for anesthesiologists whom are not accustomed to using dexmedetomidine to determine the dose during an operation. we investigated the optimal dose by evaluating respiratory rate and sedation degree for sedation under local anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the change of hemodynamics
Key secondary outcomes
the change of respiratory rate, bispectral index and saturation
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
| 20 | years-old | <= |
Age-upper limit
| 80 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with ASA performance status I or II whom were scheduled to undergo surgery in general, obstetrics and gynecological surgery, urological surgery, orthopedics surgery, dermatological surgery and plastic surgery under local anesthesia.
Key exclusion criteria
Patients whom were unconscious or refused participation of the study
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Mitsutaka Edanaga |
Organization
Sapporo Medical University School of Medicine
Division name
Department of Anesthesiology
Zip code
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
edanaka@sapmed.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Takeda |
Organization
Sapporo Medical University School of Medicine
Division name
Hospital Division
Zip code
Address
S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan
TEL
011-611-2111
Homepage URL
hiroshi.takeda@sapmed.ac.jp
Sponsor or person
Institute
Sapporo Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Sapporo Medical 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
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 | 04 | Month | 28 | 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
| 2013 | Year | 07 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 09 | Month | 06 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
intervention study
Management information
Registered date
| 2015 | Year | 04 | Month | 27 | Day |
Last modified on
| 2017 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020010
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| Registered date | File name |
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