UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002545 |
|---|---|
| Receipt number | 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 19:11:53 |
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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 ≥ 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
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
Sponsor or person
Institute
Yeungnam University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003111
