UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000021688
Receipt number R000025018
Scientific Title the evaluation of the appropriate dose of dexmedetomidine under Sedline which is the new monitoring for the degree of sedation
Date of disclosure of the study information 2016/03/31
Last modified on 2018/12/10 16:09:49

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Basic information

Public title

the evaluation of the appropriate dose of dexmedetomidine under Sedline which is the new monitoring for the degree of sedation

Acronym

the evaluation of the appropriate dose of dexmedetomidine under Sedline which is the new monitoring for the degree of sedation

Scientific Title

the evaluation of the appropriate dose of dexmedetomidine under Sedline which is the new monitoring for the degree of sedation

Scientific Title:Acronym

the evaluation of the appropriate dose of dexmedetomidine under Sedline which is the new monitoring for the degree of sedation

Region

Japan


Condition

Condition

the patients proposed operation under local anesthesia

Classification by specialty

Anesthesiology Operative medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

We compare the degree of sedation by middle dose of dexmedetomidine with minimum dose of it during using Sedline which is the monitoring for evaluation of the degree of sedation

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

the change of the degree of sedation, respiratory rate, oxygenation, systolic blood pressure and heart rate at every 15 minutes, and RASS score at the operation finished

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine Device,equipment

Interventions/Control_1

low dose of dexmedetomidine group: 6 microgram/kg /hr dexmedetomidine was administered over a period of 10 minutes as a loading dose, and then maintenance infusion (0.2 microgram/kg/hr) was started.

Interventions/Control_2

middle dose of dexmedetomidine group: 6 microgram/kg /hr dexmedetomidine was administered over a period of 10 minutes as a loading dose, and then maintenance infusion (0.4 microgram/kg/hr) was started.

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

60 years-old >

Gender

Male and Female

Key inclusion criteria

the patients which has ASA PS I or II and proposed operation under local anesthesia

Key exclusion criteria

the patients who has difficulty in mutual understanding , has difficulty to get cooperation, has cardiovascular or respiratory or neurological complication

Target sample size

50


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Mitsutaka Edanaga

Organization

Sapporo Medical University School of Medicine

Division name

Department of Anesthesiology

Zip code


Address

S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-688-9663

Email

edanaka@sapmed.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Kouji Hamaya

Organization

Sapporo Medical University School of Medicine

Division name

Hospital section

Zip code


Address

S1, W16, Chuo-ku, Sapporo, Hokkaido, Japan

TEL

011-611-2111

Homepage URL


Email

ko-hamaya-923@sapmed.ac.jp


Sponsor or person

Institute

Sapporo Medical University School of Medicine

Institute

Department

Personal name



Funding Source

Organization

Department of Anesthesiology, Sapporo Medical University School of Medicine

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

2016 Year 03 Month 31 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

2016 Year 02 Month 17 Day

Date of IRB


Anticipated trial start date

2016 Year 04 Month 01 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

2016 Year 03 Month 30 Day

Last modified on

2018 Year 12 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025018


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name