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

Email

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


Email

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


Email



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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name