UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023511 |
|---|---|
| Receipt number | R000027087 |
| Scientific Title | Evaluation for the peripheral circulation of upper limb under spinal anesthesia with or without dexmedetomidine. |
| Date of disclosure of the study information | 2016/08/07 |
| Last modified on | 2016/08/05 20:04:01 |
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Basic information
Public title
Evaluation for the peripheral circulation of upper limb under spinal anesthesia with or without dexmedetomidine.
Acronym
Evaluation for the peripheral circulation under spinal anesthesia.
Scientific Title
Evaluation for the peripheral circulation of upper limb under spinal anesthesia with or without dexmedetomidine.
Scientific Title:Acronym
Evaluation for the peripheral circulation under spinal anesthesia.
Region
| Japan |
Condition
Condition
patients undergoing elective surgery under spinal anesthesia.
Classification by specialty
| Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We estimate peripheral circulation of upper limb under spinal anesthesia by Radical-7. In addition, we estimate effect of dexmedetomidine to peripheral circulation of upper limb under spinal anesthesia.
Basic objectives2
Pharmacodynamics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
perfusion index, pleth variability index
Key secondary outcomes
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients who undergo surgery under spinal anesthesia with ASA-PS 1 or 2.
Key exclusion criteria
Age<20, pregnant, patients who undergo surgery using Tourniquet.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kenichiro Koda |
Organization
Toho University Sakura Medical Center
Division name
Department of Anesthesiology
Zip code
Address
564-1, Simoshizu, Sakura-shi, Chiba
TEL
043-462-8811
kenich-kou@sakura.med.toho-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Koda |
Organization
Toho University Sakura Medical Center
Division name
Department of Anesthesiology
Zip code
Address
564-1, Simoshizu, Sakura-shi, Chiba
TEL
043-462-8811
Homepage URL
kenich-kou@sakura.med.toho-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Toho University Sakura Medical Center
Institute
Department
Personal name
Funding Source
Organization
Toho 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
東邦大学医療センター佐倉病院（千葉県）
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 08 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 01 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 08 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Patients are recruited if they undergo surgery with spinal anesthesia in our hospital from Aug 8 2016 and are matched with the criteria. We measure PI and PVI under spinal anesthesia. If patients want to sleep during surgery, we put them under sedation with dexmedetomidine and measure PI and PVI. This is observational study and does not involve any intervention. Twenty patients will be recruited in each group(no sedation group, dexmedetomidine group).
Management information
Registered date
| 2016 | Year | 08 | Month | 05 | Day |
Last modified on
| 2016 | Year | 08 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027087
