UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059160 |
|---|---|
| Receipt number | R000065996 |
| Scientific Title | A study of the effects of changes in patency of the airway during dental sedation on tissue blood flow and stress. |
| Date of disclosure of the study information | 2025/10/01 |
| Last modified on | 2025/10/02 20:01:33 |
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Basic information
Public title
A study of the relationship between airway and stress during dental sedation.
Acronym
A study of the relationship between airway and stress during dental sedation.
Scientific Title
A study of the effects of changes in patency of the airway during dental sedation on tissue blood flow and stress.
Scientific Title:Acronym
A study of the effects of changes in patency of the airway during dental sedation on tissue blood flow and stress.
Region
| Japan |
Condition
Condition
Dental Anesthesiology
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
One of the adverse events in sedation is obstruction of the airway and consequent hypoxemia. Nasopharyngeal tube is one of the ways to improve patency of the airway. This study evaluates the effects of airway obstruction during sedation and changes in patency of the airway induced by nasopharyngeal tube on tissue blood flow, tissue oxygenation, and stress.
Basic objectives2
Others
Basic objectives -Others
This study aims to improve the safety of dental sedation by evaluating the effects of airway obstruction during sedation and changes in patency of the airway by the nasopharyngeal tube on tissue blood flow, tissue oxygenation, and stress.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1) Evaluation of respiration and oxygenation:
1. The number of apneas (pAHI), degree of snoring, peripheral vascular blood flow (PAT amplitude), and arousal state are continuously recorded using the WatchPat 300 (sleep evaluation device).
2. Exhaled end-expiratory partial pressure of carbon dioxide (EtCO2) and capnogram are recorded by capnography. EtCO2 is recorded every 15 minutes in the anesthesia record.
Oxygen saturation is measured by measuring SpO2 using a pulse oximeter.
2) Evaluation of tissue blood flow:
1. Brain tissue blood flow and oxygenation caused by changes in respiration during sedation will be evaluated using NIRO 200nx (Near Infrared Spectroscopy) and recorded continuously.
3) Evaluation of stress:
1. The effects of changes in respiration during sedation on autonomic nervous system activity will be evaluated using my Beat (heart rate variability analyzer) and recorded continuously.
2. Cortisol, sIgA, sIgG, and amylase will be measured using the SOMA CUBE Reader (salivary stress marker analyzer) to evaluate the effects on stress. Saliva samples are collected 2 minutes prior to body position change.
Key secondary outcomes
1) Record the subject's basic information:
Age, gender, height, weight, current medical history, medical history, medication status, amount of mouth opening/ distance between mussel hyoid bones/ distance between hyoid bones thyroid cartilage, tongue size, presence of enlarged tonsils, number of remaining teeth, presence of cervical backbending restriction, frequency of habitual snoring.
2) Vital signs during and before and after sedation:
Blood pressure, pulse rate, heart rate, SpO2, respiratory rate
3) Assessment of sedation level:
Evaluated by electroencephalogram monitoring (BIS), OAA/S score, and the definition of sedation depth in the sedation guidelines of the American Society of Anesthesiologists.
4) Subject's Impression:
After sedation, the subject's satisfaction with sedation and discomfort related to the use of the nasopharyngeal tube will be evaluated using the Visual Analogue Scale (VAS).
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Other |
Interventions/Control_1
This study is a Cohot study in which the same subjects were sedated and each parameter was measured before and after the use of a nasopharyngeal tube.
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
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adults (1 or 2 in the American Society of Anaesthesiologists' Classification of Systemic Conditions (ASA-PS classification))
Key exclusion criteria
1) If there is habitual mouth breathing or if the patient is reported to be prone to epistaxis
2) Inflammation or tumour of the nasal cavity, suspected skull base fracture
3) If there is a history of chronic obstructive pulmonary disease (COPD)
4) If allergic to any of the drugs used (Propofol, Midazolam, Flumazenil)
5) If the EEG cannot be measured accurately, e.g. history of epilepsy
6) If the patient is taking antithrombotic or anticoagulant medication
7) If the patient is unable to comply with the no eating or drinking times (no food: 6 hours before the procedure No water: 3 hours before the procedure)
8) If consent to participate in the study cannot be obtained
9) If the principal investigator considers the patient to be unsuitable for participation in the study
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | HIDETAKA |
| Middle name | |
| Last name | KURODA |
Organization
KANAGAWA DENTAL UNIVERSITY
Division name
Department of Anesthesiology, Division of Dental Anesthesiology
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa
TEL
0468228751
kuroda@kdu.ac.jp
Public contact
Name of contact person
| 1st name | HIDETAKA |
| Middle name | |
| Last name | KURODA |
Organization
KANAGAWA DENTAL UNIVERSITY
Division name
Department of Anesthesiology, Division of Dental Anesthesiology
Zip code
2380003
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa
TEL
0468228751
Homepage URL
kuroda@kdu.ac.jp
Sponsor or person
Institute
KANAGAWA DENTAL UNIVERSITY
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
KANAGAWA DENTAL UNIVERSITY
Address
82 Inaoka-cho, Yokosuka-shi, Kanagawa
Tel
0468228751
kenkyo@kdu.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
神奈川歯科大学附属病院
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2025 | Year | 04 | Month | 01 | Day |
Date of IRB
| 2025 | Year | 04 | Month | 18 | Day |
Anticipated trial start date
| 2025 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2027 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2027 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2027 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2025 | Year | 09 | Month | 22 | Day |
Last modified on
| 2025 | Year | 10 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000065996
