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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010886
Receipt No. 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

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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
Institute Osaka University Graduate School of Dentistry
Institute
Department

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
URL(English) https://upload.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


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