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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000013448
Receipt No. R000015594
Scientific Title Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Date of disclosure of the study information 2014/03/19
Last modified on 2018/08/29

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Basic information
Public title Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Acronym Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Scientific Title Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Scientific Title:Acronym Comparison of dexmedetomidine and propofol for conscious sedation in dental surgery
Region
Japan

Condition
Condition adult patients who need intravenous sedation for dental surgery
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate of clinical utility for conscious sedation by comparing dexmedetomidine sedation to propofol sedation.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase IV

Assessment
Primary outcomes unexpected patient movements
Key secondary outcomes responsiveness, mouth opening time, cough reflex, snoring, total and rescue dose of midazolam, patient and operator satisfaction, memory of the procedure, recovery behaviour after sedation.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking YES
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 conscious sedation with midazolam (Dormicum) and dexmedetomidine (Precedex).
Interventions/Control_2 conscious sedation with midazolam (Dormicum) and propofol (Diprivan).
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
80 years-old >
Gender Male and Female
Key inclusion criteria adult patients who need conscious sedation for dental surgery
Key exclusion criteria patients aged over 80; ASA physical status 3 and 4; patients with contraindications to propofol, dexmedetomidine and midazolam; allergy to soybean or egg; a history of cardiovascular or respiratory disease; use of drugs for psychotropic and cardiac desease.
Target sample size 88

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 Anesthesia
Zip code
Address 1-8, Yamadaoka, Suita City, Osaka, Japan
TEL 06-6879-2972
Email hanamoto@dent.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Hanamoto
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthesia
Zip code
Address 1-8, Tamadaoka, Suita City, Osaka, Japan
TEL 06-6879-2972
Homepage URL
Email hanamoto@dent.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Osaka University Graduate School of Dentistry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor none
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
2014 Year 03 Month 19 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications https://www.sciencedirect.com/science/article/pii/S0278239118307614?via%3Dihub
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
2014 Year 02 Month 28 Day
Date of IRB
Anticipated trial start date
2014 Year 05 Month 01 Day
Last follow-up date
2017 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2014 Year 03 Month 18 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=R000015594

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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