UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000015604
Receipt number R000018130
Scientific Title Research for application to anesthesia of gabapentine that is a chemical delivative of GABA with central nervous system depressant property.
Date of disclosure of the study information 2014/11/06
Last modified on 2017/12/15 08:13:44

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Basic information

Public title

Research for application to anesthesia of gabapentine that is a chemical delivative of GABA with central nervous system depressant property.

Acronym

Research for application to anesthesia of gabapentine that is a chemical delivative of GABA with central nervous system

Scientific Title

Research for application to anesthesia of gabapentine that is a chemical delivative of GABA with central nervous system depressant property.

Scientific Title:Acronym

Research for application to anesthesia of gabapentine that is a chemical delivative of GABA with central nervous system

Region

Japan


Condition

Condition

healthy people

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To examine efficacy and safety of combined administration of gabapentine and propofol.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

blood concentration of propofol for getting around to of same depth of anesthesia

Key secondary outcomes

angialgia of propofol


Base

Study type

Interventional


Study design

Basic design

Parallel

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Placebo

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

3

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

placebo

Interventions/Control_2

group of gabapenntine 200mg

Interventions/Control_3

group of gabapenntine 400mg

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


Not applicable

Gender

Male and Female

Key inclusion criteria

based on protocol

Key exclusion criteria

based on protocol

Target sample size

10


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Shinichi Ito

Organization

kyushu university

Division name

dental anesthesiology

Zip code


Address

3-1-1 Maidashi Higashi-ku Fukuoka

TEL

092-642-6480

Email

ito@dent.kyushu-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Jun Hirokawa

Organization

kyushu university

Division name

dental anesthesiology

Zip code


Address

3-1-1 Maidashi Higashi-ku Fukuoka

TEL

092-642-6480

Homepage URL


Email

hj8823@dent.kyushu-u.ac.jp


Sponsor or person

Institute

department of dental anesthesiology, kyushu university

Institute

Department

Personal name



Funding Source

Organization

none

Organization

Division

Category of Funding Organization

Other

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

九州大学病院(福岡県)


Other administrative information

Date of disclosure of the study information

2014 Year 11 Month 06 Day


Related information

URL releasing protocol


Publication of results

Published


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

Main results already published

Date of protocol fixation

2014 Year 10 Month 27 Day

Date of IRB


Anticipated trial start date

2014 Year 11 Month 06 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 11 Month 04 Day

Last modified on

2017 Year 12 Month 15 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018130


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name