UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000009894
Receipt number R000011583
Scientific Title Examining the optimum dose of midazolam required for the vasalgia amnesia at the time of propofol infusion according to an age.
Date of disclosure of the study information 2013/01/29
Last modified on 2015/02/02 17:06:01

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Basic information

Public title

Examining the optimum dose of midazolam required for the vasalgia amnesia at the time of propofol infusion according to an age.

Acronym

propofol vasalgia

Scientific Title

Examining the optimum dose of midazolam required for the vasalgia amnesia at the time of propofol infusion according to an age.

Scientific Title:Acronym

propofol vasalgia

Region

Japan


Condition

Condition

Healthy Adult

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In intra venous anesthesia at dental-surgery, midazolam and propofol are generally used as temperantia. Propofol gives vasalgia at the time of infusion, and remains as sometimes unpleasant reminiscence. On the other hand, since midazolam generally has an antegrade amnestic effect,it is possible to vanish unpleasant reminiscence including vasalgia. But, midazolam has respiratory depressant action by airway obstruction. If it stands on the viewpoint of the use by ambulatories, or relieve of respiratory depression, the effective dose which can vanish unpleasantness reminiscence and does not cause the respiratory depression was desired.However the dose of midazolam was determined experientially until now.Then,we planned examining the optimum dose of midazolam required for the vasalgia amnesia at the time of a propofol infusion according to an age.

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Examining the optimum dose of midazolam required for the vasalgia amnesia at the time of propofol infusion according to an age

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Dose comparison

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Medicine

Interventions/Control_1

Prescription of midazolam according to updown method before infusion of propofol

Interventions/Control_2


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

70 years-old >

Gender

Male and Female

Key inclusion criteria

Healthy adult
ASA PS 1

Key exclusion criteria

Obesity

Target sample size

150


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Boku Aiji

Organization

Osaka University Graduate School of Dentistry

Division name

Department of Dental Anesthesiology

Zip code


Address

1-8, Yamadaoka, Suita, Japan

TEL

06-6879-2972

Email

bokuaiji@dent.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Boku Aiji

Organization

Osaka University Graduate School of Dentistry

Division name

Department of Dental Anesthesiology

Zip code


Address

1-8 Yamadaoka Suita Japan

TEL

06-6879-2972

Homepage URL


Email

bokuaiji@dent.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Dentistry

Institute

Department

Personal name



Funding Source

Organization

Osaka University Graduate School of Dentistry

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



Other administrative information

Date of disclosure of the study information

2013 Year 01 Month 29 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

Completed

Date of protocol fixation

2012 Year 08 Month 03 Day

Date of IRB


Anticipated trial start date

2013 Year 02 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

2013 Year 01 Month 29 Day

Last modified on

2015 Year 02 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011583


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name