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UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000004058
Receipt No. R000004808
Scientific Title Maintenance of baroreflex sensitivity during intravenous sedation with a combination of propofol and midazolam
Date of disclosure of the study information 2010/08/25
Last modified on 2012/02/20

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Basic information
Public title Maintenance of baroreflex sensitivity during intravenous sedation with a combination of propofol and midazolam
Acronym Baroreflex sensitivity during intravenous sedation
Scientific Title Maintenance of baroreflex sensitivity during intravenous sedation with a combination of propofol and midazolam
Scientific Title:Acronym Baroreflex sensitivity during intravenous sedation
Region
Japan

Condition
Condition mentally handicapped patient
dental phobia
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 This study examines whether baroreflex sensitivity during intravenous sedation with a combination of propofol and midazolam is maintained at the same level as that with propofol only. Furthermore, we evaluate the safety of combination sedation on cardiovascular control systems at doses appropriate for mentally handicapped patients to accept medical treatment.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes For analysis of spontaneous baroreflex sensitivity, we examined continuous finger arterial pressure and electrocardiograms to detect sequence changes in the R-R interval with parallel changes in arterial pressure. Our software selected all of the sequences of three or more successive heart beats in which there were concordant increases or decreases in systolic blood pressure and R-R intervals. A linear regression was applied to each of the sequences, and the mean slope during each condition was assessed as baroreflex sensitivity.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-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 We also analyzed the effect of intravenous sedation with a combination of propofol and midazolam during dental treatment of a group of mentally handicapped adult patients to evaluate the maintenance of blood pressure in such subjects.
Interventions/Control_2 Intravenous sedation using propofol only during dental treatment of another group of handicapped patients was used as a control.
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
16 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Only patients scheduled for dental treatment under intravenous sedative were recruited for this study. Written informed consent from parents or legal guardians was obtained following careful explanation of the study's procedure, risk, and benefits.
This study was performed according to guidelines set by the Declaration of Helsinki and was approved by the Institutional Review Board on Human Experiments of Matsumoto Dental University.
Key exclusion criteria Patients with serious circulatory or respiratory diseases, epilepsy, egg or buckwheat allergies, or any other serious chronic diseases were excluded from experiments.
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Sumida Sachi
Organization Matsumoto Dental University
Division name Department of Special Patients and Oral Care
Zip code
Address 1780,Goubara,Hirooka,Siojirisi,
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Matsumoto Dental University
Division name Department of Special Patients and Oral Care
Zip code
Address
TEL
Homepage URL
Email sumineko@po.mdu.ac.jp

Sponsor
Institute Matsumoto Dental University
Institute
Department

Funding Source
Organization Nagano Society for the Promotion of Science
Organization
Division
Category of Funding Organization Non profit foundation
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
2010 Year 08 Month 25 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 07 Month 30 Day
Date of IRB
Anticipated trial start date
2010 Year 08 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
2010 Year 08 Month 17 Day
Last modified on
2012 Year 02 Month 20 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004808

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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