UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009728
Receipt No. R000011403
Scientific Title Effect of combination of intravenous propofol and inhaled nitrous oxide: a randomized clinical trial
Date of disclosure of the study information 2013/01/08
Last modified on 2018/08/29

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Effect of combination of intravenous propofol and inhaled nitrous oxide: a randomized clinical trial
Acronym Effect of combination of intravenous propofol and inhaled nitrous oxide
Scientific Title Effect of combination of intravenous propofol and inhaled nitrous oxide: a randomized clinical trial
Scientific Title:Acronym Effect of combination of intravenous propofol and inhaled nitrous oxide
Region
Japan

Condition
Condition healthy adult volunteers
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study is to investigate whether N2O added to intravenous sedation with propofol can reduce the occurrence of hypotension and to improve quality of sedation.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hemodynamics, heart rate variability, depth of sedation
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
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 and intravenous propofol
Interventions/Control_2 sedation with and intravenous propofol and inhaled 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
50 years-old >
Gender Male and Female
Key inclusion criteria Healthy adult volunteers
Key exclusion criteria A history of cardiovascular disease, hypertension, respiratory disease and dysautonomia were considered criteria for exclusion from the study.
Target sample size 26

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Hanamoto
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthsiology
Zip code
Address 1-8, Yamadaoka, Suita, Osaka, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthsiology
Zip code
Address 1-8, Yamadaoka, Suita, Osaka, Japan
TEL
Homepage URL
Email

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 01 Month 08 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 Completed
Date of protocol fixation
2011 Year 06 Month 21 Day
Date of IRB
Anticipated trial start date
2011 Year 06 Month 21 Day
Last follow-up date
2012 Year 02 Month 22 Day
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 08 Day
Last modified on
2018 Year 08 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011403

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.