UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000010886
Receipt number R000012741
Scientific Title Effect of sedation with a combination of intravenous propofol and inhaled nitrous oxide
Date of disclosure of the study information 2013/06/06
Last modified on 2014/03/18 10:15:00

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Basic information

Public title

Effect of sedation with a combination of intravenous propofol and inhaled nitrous oxide

Acronym

Sedation with a combination of intravenous propofol and inhaled nitrous oxide

Scientific Title

Effect of sedation with a combination of intravenous propofol and inhaled nitrous oxide

Scientific Title:Acronym

Sedation with a combination of intravenous propofol and inhaled nitrous oxide

Region

Japan


Condition

Condition

patiants who need intravanous sedation during dental procedure

Classification by specialty

Dental medicine

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The purpose of this study is to investigate whether combination technique of inhaled nitrous oxide and intravenous propofol can improve adverse reaction of intravenous sedation.

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

circulationdynamics, depth of sedation, adverse effect

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

sedation with propofol

Interventions/Control_2

sedation with propofol and nitrous oxide

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

Adult patiants, ASA physical status 1 or 2, who need intravenous sedation for dental procedure

Key exclusion criteria

patiants contraindicated to use ofpropofol or nitrous oxide
ASA physical status 3 or 4
aged over 70 years
aged under 20 years

Target sample size

100


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Chizuko Yokoe

Organization

Osaka University Graduate School of Dentistry

Division name

Department of dental anesthesiology

Zip code


Address

1-8, Yamadaoka, Suita City, Osaka, Japan

TEL

06-6879-2972

Email

yokoe@dent.osaka-u.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Chizuko Yokoe

Organization

Osaka University Graduate School of Dentistry

Division name

Department of dental anesthesiology

Zip code


Address

1-8, Yamadaoka, Suita City, Osaka, Japan

TEL

06-6879-2972

Homepage URL


Email

yokoe@dent.osaka-u.ac.jp


Sponsor or person

Institute

Osaka University Graduate School of Dentistry

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

2013 Year 06 Month 06 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

2010 Year 11 Month 22 Day

Date of IRB


Anticipated trial start date

2010 Year 11 Month 22 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 06 Month 05 Day

Last modified on

2014 Year 03 Month 18 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012741


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name