UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000018600
Receipt No. 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 (Ver. 10)

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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
Email 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
Email kohyu@dent.showa-u.ac.jp

Sponsor
Institute Showa University Koto Toyou Hospital Department of Anesthesiology
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021525