UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013558 |
|---|---|
| Receipt number | R000015840 |
| Scientific Title | Examination of the proper dose of dexmedetomidine sedation in spinal subarachnoid anesthesia |
| Date of disclosure of the study information | 2014/03/30 |
| Last modified on | 2014/03/30 00:54:56 |
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Basic information
Public title
Examination of the proper dose of dexmedetomidine sedation in spinal subarachnoid anesthesia
Acronym
Examination of the proper dose of dexmedetomidine sedation in spinal subarachnoid anesthesia
Scientific Title
Examination of the proper dose of dexmedetomidine sedation in spinal subarachnoid anesthesia
Scientific Title:Acronym
Examination of the proper dose of dexmedetomidine sedation in spinal subarachnoid anesthesia
Region
| Japan |
Condition
Condition
case of spinal anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to use the dexmedetomidine as a sedative spinal subarachnoid anesthesia, consider the appropriate dosage.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Circulation, breathing, conscious state, satisfaction of sadation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
The dose of sedative agent
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients undergoing elective surgery in spinal subarachnoid anesthesia
Key exclusion criteria
Cases of impaired in respiratory or circulatory reserve
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiko Sugita |
Organization
Kumamoto university hospital
Division name
Anesthesiology
Zip code
Address
1-1-1 honjo chuo-ku kumamoto
TEL
096-373-5275
msugita@kumamoto-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Michiko Sugita |
Organization
Kumamoto university hospital
Division name
Anesthesiology
Zip code
Address
1-1-1 honjo chuo-ku kumamoto
TEL
096-373-5275
Homepage URL
msugita@kumamoto-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Kumamoto university
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Kumamoto university
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
| 2014 | Year | 03 | 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
Enrolling by invitation
Date of protocol fixation
| 2013 | Year | 10 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 03 | Month | 30 | 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
| 2014 | Year | 03 | Month | 30 | Day |
Last modified on
| 2014 | Year | 03 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015840
