UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Low dose dexmedetomidine inhibit post operative nausea and vomitting and shivering post brain tumor resection. Double Blind Randomized Control Trial
Title of the study (Brief title)	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	Shunsuke Takaki
Organization	Yokohama City University Hospital
Division name	Intensive Care Unit
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	045-787-2918
Email	shunty5323@gmail.com

Public contact
Name of contact person	shunsuke takaki
Organization	Yokohama City University Hospital
Division name	Intensive Care Unit
Address	3-9 Fukuura Kanazawaku Yokohama
TEL	045-787-2918
Homepage URL
Email	shunty5323@gmail.com

Sponsor
Institute	Yokohama City University Department of Anesthesiology
Institute
Department

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2015 Year 09 Month 30 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022129