UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012775 |
|---|---|
| Receipt number | R000014923 |
| Scientific Title | Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia. |
| Date of disclosure of the study information | 2014/01/07 |
| Last modified on | 2022/10/28 18:28:32 |
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Basic information
Public title
Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia.
Acronym
Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia.
Scientific Title
Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia.
Scientific Title:Acronym
Effects of dexmedetomidine on hemodynamic changes during spinal anesthesia.
Region
| Japan |
Condition
Condition
Patients undergoing elective surgery under spinal anesthesia.
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate whether the timing of dexmedetomidine administration affect hemodynamic changes in spinal anesthesia.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Blood plessure changes after spinal anesthesia.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention:Start dexmedetomidine administration at the same time as local anesthesia injection.
Interventions/Control_2
Control:Start dexmedetomidine administration at 15 minutes after local anesthesia injection.
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
| 55 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients with ASA Physical status 1 or 2
Key exclusion criteria
Obesity (BMI>35)
Hypertension
Patient with a history of cardiac disease.
Patient who don't wish to sedation.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Ayana |
| Middle name | |
| Last name | Kanaya |
Organization
Japan Self Defense Force Hospital Yokosuka
Division name
Department of Anesthesiology
Zip code
2370071
Address
1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL
046-823-0270
sweetberryst@gmail.com
Public contact
Name of contact person
| 1st name | Takahiro |
| Middle name | |
| Last name | Ogura |
Organization
Japan Self Defense Force Hospital Yokosuka
Division name
Department of Anesthesiology
Zip code
2370071
Address
1766-1 Tauraminatocho, Yokosuka, Kanagawa
TEL
046-823-0270
Homepage URL
dr21032@ndmc.ac.jp
Sponsor or person
Institute
Japan Self Defense Force Hospital Yokosuka
Institute
Department
Personal name
Funding Source
Organization
None
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
Japan self defense force Hospital Yokosuka
Address
1766-1 Tauramiatocho Yokosuka Kanagawa
Tel
046-823-0270
yhl-hsoumu@inet.msdf.mod.go.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
自衛隊横須賀病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 01 | Month | 07 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://iss.ndl.go.jp/books/R000000004-I030530794-00
Number of participants that the trial has enrolled
20
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 | 12 | Month | 05 | Day |
Date of IRB
| 2013 | Year | 12 | Month | 26 | Day |
Anticipated trial start date
| 2014 | Year | 01 | Month | 07 | Day |
Last follow-up date
| 2022 | Year | 07 | Month | 31 | 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 | 01 | Month | 07 | Day |
Last modified on
| 2022 | Year | 10 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014923
| 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 |
