UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Examination of sedative effects of dexmedetomidine during chronic subdural hematoma surgery under local anesthesia: prospective randomized control trial
Title of the study (Brief title)	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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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	Yuko Kondo
Organization	Nihon University School of Medicine
Division name	Division of Anesthesiology, Department of Anesthesiology
Address	30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Email	kondo.yuko@nihon-u.ac.jp

Public contact
Name of contact person	Yuko Kondo
Organization	Nihon University School of Medicine
Division name	Division of Anesthesiology, Department of Anesthesiology
Address	30-1, Oyaguchi-Kamicho, Itabashi-ku, Tokyo, Japan
TEL	03-3972-8111
Homepage URL
Email	kondo.yuko@nihon-u.ac.jp

Sponsor
Institute	Nihon University School of Medicine
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status	Terminated
Date of protocol fixation	2014 Year 05 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000016211