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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007459
Receipt No. R000008796
Scientific Title Cough reflex under intravenous sedation during dental implant surgery
Date of disclosure of the study information 2012/03/06
Last modified on 2013/01/07

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Basic information
Public title Cough reflex under intravenous sedation during dental implant surgery
Acronym Cough reflex under intravenous sedation during dental implant surgery
Scientific Title Cough reflex under intravenous sedation during dental implant surgery
Scientific Title:Acronym Cough reflex under intravenous sedation during dental implant surgery
Region
Japan

Condition
Condition missing teeth
Classification by specialty
Dental medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The purpose of this study was to investigate how often the cough reflex occurs, what is associated with the occurrence of the cough reflex, and what situations induce it.
Basic objectives2 Others
Basic objectives -Others observational investigation
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes surgical procedure, surgical region
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
100 years-old >=
Gender Male and Female
Key inclusion criteria patients who are scheduled for dental implant surgery under intravenous sedation
Key exclusion criteria patients with dysphagia
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hiroshi Hanamoto
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthsiology
Zip code
Address 1-8, Yamadaoka, Suita, Osaka
TEL 06-6879-2972
Email

Public contact
Name of contact person
1st name
Middle name
Last name Hiroshi Hanamoto
Organization Osaka University Graduate School of Dentistry
Division name Department of Dental Anesthsiology
Zip code
Address 1-8, Yamadaoka, Suita, Osaka
TEL 06-6879-2972
Homepage URL
Email

Sponsor
Institute Osaka University Graduate School of Dentistry
Institute
Department

Funding Source
Organization Osaka University
Organization
Division
Category of Funding Organization
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
2012 Year 03 Month 06 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
2009 Year 09 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 09 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 Intraoperatively, if the patient coughed, the surgical procedure and the area being stimulated are recorded.

Management information
Registered date
2012 Year 03 Month 06 Day
Last modified on
2013 Year 01 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008796

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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