UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000013904 |
|---|---|
| Receipt number | R000016211 |
| Scientific Title | Examination of sedative effects of dexmedetomidine during chronic subdural hematoma surgery under local anesthesia: prospective randomized control trial |
| Date of disclosure of the study information | 2014/05/09 |
| Last modified on | 2016/06/12 19:05:40 |
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Basic information
Public title
Examination of sedative effects of dexmedetomidine during chronic subdural hematoma surgery under local anesthesia: prospective randomized control trial
Acronym
Sedative effects of dexmedetomidine during chronic subdural hematoma surgery under local anesthesia
Scientific Title
Examination of sedative effects of dexmedetomidine during chronic subdural hematoma surgery under local anesthesia: prospective randomized control trial
Scientific Title:Acronym
Sedative effects of dexmedetomidine during chronic subdural hematoma surgery under local anesthesia
Region
| Japan |
Condition
Condition
Chronic subdural hematoma patient
Classification by specialty
| Anesthesiology | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Efficacy of dexmedetomidine versus propofol when used for intraoperative sedation
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Efficancy and side effects of dexmedetomidine versus propofol when used for intraoperative sedation under local anesthesia
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Single blind -participants are 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 for intraoperative sedation
Interventions/Control_2
Propofol for intraoperative sedation
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
Chronic subdural hematoma patient undergoing surgery under local anesthesia
Key exclusion criteria
Patient with liver, renal dysfunction or arrhythmia
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yuko Kondo |
Organization
Nihon University School of Medicine
Division name
Division of Anesthesiology, Department of Anesthesiology
Zip code
Address
30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
kondo.yuko@nihon-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yuko Kondo |
Organization
Nihon University School of Medicine
Division name
Division of Anesthesiology, Department of Anesthesiology
Zip code
Address
30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL
03-3972-8111
Homepage URL
kondo.yuko@nihon-u.ac.jp
Sponsor or person
Institute
Nihon University School of Medicine
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
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 | 05 | Month | 09 | 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 | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 05 | 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
Management information
Registered date
| 2014 | Year | 05 | Month | 08 | Day |
Last modified on
| 2016 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016211
