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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002545
Receipt No. R000003111
Scientific Title Jaw-thrust may induce sympathetic responses
Date of disclosure of the study information 2009/09/25
Last modified on 2009/09/25

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Basic information
Public title Jaw-thrust may induce sympathetic responses
Acronym Jaw-thrust and sympathetic response
Scientific Title Jaw-thrust may induce sympathetic responses
Scientific Title:Acronym Jaw-thrust and sympathetic response
Region
Asia(except Japan)

Condition
Condition Airway obstruction
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 No previous report has specifically evaluated whether jaw-thrust induces the sympathetic responses. To assess this, we used endoscopy for applying adequate force to the posterior rami of the mandible for jaw-thrust, and measured the increase in systemic arterial pressure (AP) and heart rate (HR) as sympathetic responses to jaw-thrust under general anaesthesia.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes We found that jaw-thrust with the endoscopy-guided force application increases AP and HR, indicating that jaw-thrust induces the exaggerated sympathetic responses. The magnitude of the force applied is not related to that of the responses.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Double blind -all involved are blinded
Control No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Applying Jaw-thrust to patients
Interventions/Control_2 Applying nothing
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
40 years-old <=
Age-upper limit
70 years-old >
Gender Male and Female
Key inclusion criteria Healthy patients requiring general anesthesia
Key exclusion criteria Patients with the following criteria: history of oral, pharyngo-laryngeal or tracheal surgery or pathology; patients with body mass index &#8805; 30; patients with loose denture or edentulous patients.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Daelim Jee
Organization Yeungnam University College of Medicine
Division name Anesthesiology and Pain Medicine
Zip code
Address Daemyung-Dong, Nam-Gu, Daegu, Korea
TEL +82-53-620-3367
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Yeungnam University College of Medicine
Division name Anesthesiology and Pain Medicine
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Yeungnam University
Institute
Department

Funding Source
Organization Yeungnam University
Organization
Division
Category of Funding Organization Outside Japan
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
2009 Year 09 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
2009 Year 03 Month 20 Day
Date of IRB
Anticipated trial start date
2009 Year 03 Month 01 Day
Last follow-up date
2009 Year 06 Month 01 Day
Date of closure to data entry
2009 Year 06 Month 01 Day
Date trial data considered complete
2009 Year 06 Month 01 Day
Date analysis concluded
2009 Year 06 Month 01 Day

Other
Other related information

Management information
Registered date
2009 Year 09 Month 25 Day
Last modified on
2009 Year 09 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003111

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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