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

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 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

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

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021525


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name