UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018600 |
|---|---|
| Receipt number | R000021525 |
| Scientific Title | Effects of sedation on breathing in patients undergoing dental sedation. |
| Date of disclosure of the study information | 2015/08/08 |
| Last modified on | 2019/08/13 16:33:28 |
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Basic information
Public title
Effects of sedation on breathing in patients undergoing dental sedation.
Acronym
Respiratory effects of dental sedation.
Scientific Title
Effects of sedation on breathing in patients undergoing dental sedation.
Scientific Title:Acronym
Respiratory effects of dental sedation.
Region
| Japan |
Condition
Condition
Patients undergoing dental sedation
Classification by specialty
| Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To assess respratory condition in patients undergoing dental sedation.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Freaquency of abnormal breathing patterns during the sedation.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Using of nasal airway.
Interventions/Control_2
Not using of nasal airway
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Adult patients scheduled for surgeries undergoing dental sedation.
Key exclusion criteria
Patients with ASA class greater than 3.
Omission from the protocol.
Target sample size
46
Research contact person
Name of lead principal investigator
| 1st name | Yuuya |
| Middle name | |
| Last name | Kohzuka |
Organization
Showa University Koto Toyou Hospital
Division name
Department of Anesthesiology
Zip code
135-8577
Address
5-1-38, Toyosu, Koto-ku, Tokyo, Japan
TEL
03-6204-6000
kohyu@dent.showa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuuya |
| Middle name | |
| Last name | Kohzuka |
Organization
Showa University Koto Toyou Hospital
Division name
Department of Anesthesiology
Zip code
135-8577
Address
5-1-38, Toyosu, Koto-ku, Tokyo, Japan
TEL
03-6204-6000
Homepage URL
kohyu@dent.showa-u.ac.jp
Sponsor or person
Institute
Showa University Koto Toyou Hospital Department of Anesthesiology
Institute
Department
Personal name
Funding Source
Organization
Institutional
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
Institutional Review Board
Address
5-1-38, Toyosu, Koto-ku, Tokyo, Japan
Tel
03-6204-6000
th_irb@ofc.showa-u.ac.jp
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
| 2015 | Year | 08 | Month | 08 | Day |
Related information
URL releasing protocol
https://upload.umin.ac.jp/cgi-open-bin/ctr/ctr.cgi?function=history&action=list&type=summary&recptno
Publication of results
Partially published
Result
URL related to results and publications
https://anesthesiology.pubs.asahq.org/article.aspx?articleid=2728539
Number of participants that the trial has enrolled
62
Results
In the control group, a median abnormal breathing index, including all patterns of abnormal breathing, was 48.0 h-1, and non-desaturated abnormal breathing index was higher than the desaturated abnormal breathing index (35.2 vs. 7.2 h-1, p<0.001).
The nasopharyngeal tube did not significantly reduce the abnormal breathing index (48.0 vs. 5035 h-1, p=0.846).
Results date posted
| 2019 | Year | 08 | Month | 13 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
A majority of the patients
were relatively young and nonobese and had low likelihood
of obstructive sleep apnea. There were no significant differences
in the demographic variables between the groups.
Participant flow
A total of 62 patients scheduled for dental operation under intravenous sedation were initially invited, and 46 patients gave consent to participate in this study from August 2015 to March 2016. In total, 43 patients completed the study protocol (control group: n = 23, nasopharyngeal tube group: n = 20).
Adverse events
NA
Outcome measures
Abnormal breathing was predetermined
by the portable sleep apnea monitor based on five expected features of abnormal breathing: (1) obstructive or central, (2) apnea or hypopnea, (3) with or without desaturation, (4) with or without irregular breathing, and (5) bradypnea or tachypnea.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2015 | Year | 06 | Month | 26 | Day |
Date of IRB
| 2015 | Year | 05 | Month | 08 | Day |
Anticipated trial start date
| 2015 | Year | 08 | Month | 08 | Day |
Last follow-up date
| 2016 | Year | 03 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 08 | Month | 08 | Day |
Last modified on
| 2019 | Year | 08 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021525
