UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014002 |
|---|---|
| Receipt number | R000016312 |
| Scientific Title | The Respiratory effects of Dexmedetomidine Versus Propofol for sedation during Spinal Anesthesia |
| Date of disclosure of the study information | 2015/02/01 |
| Last modified on | 2020/11/24 08:17:05 |
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Basic information
Public title
The Respiratory effects of Dexmedetomidine Versus Propofol for sedation during Spinal Anesthesia
Acronym
Dexmedetomidine Versus Propofol for sedation during Spinal Anesthesia
Scientific Title
The Respiratory effects of Dexmedetomidine Versus Propofol for sedation during Spinal Anesthesia
Scientific Title:Acronym
Dexmedetomidine Versus Propofol for sedation during Spinal Anesthesia
Region
| Japan |
Condition
Condition
patients scheduled for elective surgery using spinal anesthesia
Classification by specialty
| Anesthesiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the respiratory effects of dexmedetomidine and propofol for sedation during spinal anesthesia
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Respiratory rate, Tidal volume, Ventilation distribution
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
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
dexmedetomidine
Interventions/Control_2
propofol
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
pationts scheduled for elective surgery using spinal anesthesia
Key exclusion criteria
under 20 years old
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kiyoko |
| Middle name | |
| Last name | Bito |
Organization
Showa University School of Medicine
Division name
Anesthesiology
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawa, Tokyo, Japan
TEL
03-3784-8575
kiyokobitoxxx@s5.dion.ne.jp
Public contact
Name of contact person
| 1st name | Kiyoko |
| Middle name | |
| Last name | Bito |
Organization
Showa University School of Medicine
Division name
Anesthesiology
Zip code
1428666
Address
1-5-8, Hatanodai, Shinagawa, Tokyo, Japan
TEL
03-3784-8575
Homepage URL
kiyokobitoxxx@s5.dion.ne.jp
Sponsor or person
Institute
Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Department of Anesthesiology, Showa University School of Medicine
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
Showa university
Address
1-5-8, Hatanodai,
Tel
0337848000
kiyokobitoxxx@s5.dion.ne.jp
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 | 02 | 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
| 2014 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2014 | Year | 06 | Month | 01 | Day |
Anticipated trial start date
| 2014 | Year | 06 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 06 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 05 | Month | 19 | Day |
Last modified on
| 2020 | Year | 11 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016312
