UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004058 |
|---|---|
| Receipt number | 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 08:51:47 |
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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
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
sumineko@po.mdu.ac.jp
Sponsor or person
Institute
Matsumoto Dental University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004808
