UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019139 |
|---|---|
| Receipt number | R000022129 |
| Scientific Title | Low dose dexmedetomidine inhibit post operative nausea and vomitting and shivering post brain tumor resection. Double Blind Randomized Control Trial |
| Date of disclosure of the study information | 2015/10/01 |
| Last modified on | 2017/07/05 12:45:27 |
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Basic information
Public title
Low dose dexmedetomidine inhibit post operative nausea and vomitting and shivering post brain tumor resection. Double Blind Randomized Control Trial
Acronym
The effect of low dose dexmedetomidine after neurosurgery.
Scientific Title
Low dose dexmedetomidine inhibit post operative nausea and vomitting and shivering post brain tumor resection. Double Blind Randomized Control Trial
Scientific Title:Acronym
The effect of low dose dexmedetomidine after neurosurgery.
Region
| Japan |
Condition
Condition
Brain tumor
Classification by specialty
| Anesthesiology | Neurosurgery | Intensive care medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is whether low dose dexmedetomidine inhibit PONV.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
the incidence of PONV.
Key secondary outcomes
The incidence of shivering and the variation of hemodynamics changes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
low dose dexmedetomidine is started at the timing of resection of brain tumor as 0.3 mcg/kg/hr of administration speed. Then it is administered totally 40ml.
Interventions/Control_2
normal saline is started at the timing of resection of brain tumor. Administration speed is determined same as 0.3mcg/kg/hr if drug is allocated to dexmedetomidine group. Then normal saline is administered totally 40 ml.
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients who planed brain tumor resection, and obtained informed consent for participation of this study.
Key exclusion criteria
under 18 years old, not obtained informed consent, transferred to ICU under ventilation, insufficient data.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shunsuke Takaki |
Organization
Yokohama City University Hospital
Division name
Intensive Care Unit
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
045-787-2918
shunty5323@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | shunsuke takaki |
Organization
Yokohama City University Hospital
Division name
Intensive Care Unit
Zip code
Address
3-9 Fukuura Kanazawaku Yokohama
TEL
045-787-2918
Homepage URL
shunty5323@gmail.com
Sponsor or person
Institute
Yokohama City University Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Yokohama City University Department of Anesthesiology
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
横浜市立大学附属病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 10 | 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
| 2015 | Year | 09 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 12 | Month | 10 | 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
| 2015 | Year | 09 | Month | 28 | Day |
Last modified on
| 2017 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022129
