UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000054973 |
|---|---|
| Receipt number | R000062812 |
| Scientific Title | Investigate the effects of anesthetics on salivary function |
| Date of disclosure of the study information | 2024/07/16 |
| Last modified on | 2024/08/26 12:43:06 |
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Basic information
Public title
Subjective and objective evaluation of salivary secretion in oral surgery under general anesthesia.
Acronym
To determine changes in salivary secretion during general anesthesia.
Scientific Title
Investigate the effects of anesthetics on salivary function
Scientific Title:Acronym
Relationship between anesthetics and salivary function
Region
| Japan |
Condition
Condition
Patients over 20 years old who will undergo oral surgery under general anesthesia at Kanagawa Dental University Hospital.
Classification by specialty
| Oral surgery | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Subjective or objective assessment of saliva production to determine how anesthetics affect saliva production
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Subjective evaluation (salivation and discomfort) using Visual analogue scale from oral surgeon during pharyngeal pack insertion
Key secondary outcomes
1. amount of saliva aspiration during tracheal intubation
2. subjective evaluation (salivation and stress) by dental anesthesiologist using Visual Analogue Scale during tracheal intubation
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Anesthetic agents used in induction and maintenance of anesthesia in general anesthesia = Remimazolam
Interventions/Control_2
Anesthetic agents used in induction and maintenance of anesthesia in general anesthesia = Propofol
Interventions/Control_3
Anesthetic agents used in induction of general anesthesia = Propofol, and anesthetic agents used in maintenance of general anesthesia = Inhaled anesthetic agents.
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
Patients over 20 years old who will undergo oral surgery under general anesthesia at Kanagawa Dental University Hospital
Key exclusion criteria
1. people with an ASA-PS of 3 or higher
2. patients who are aware of thirst or are taking drugs that cause thirst
3. patients who have the following on blood drawn prior to the preoperative visit
AST (GOT) or ALT (GPT) greater than 100 IU/L
Serum creatinine > 2.0 mg/dL
HbA1c greater than or equal to 7.5
4. taking benzodiazepines for more than 6 months
5. whose EEG and BIS values may not be properly measured (including vascular lesions)
6. who have a cardiac pacemaker or ICD
7. who have expressed (including verbally) their refusal to participate in this study
8. other subjects deemed inappropriate by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kanagawa Dental University
Division name
Department of Dental Anesthesiology
Zip code
238-8570
Address
1-23, Ogawa-cho, Yokosuka, Kanagawa
TEL
046-822-8810
tsukimoto@kdu.ac.jp
Public contact
Name of contact person
| 1st name | Shota |
| Middle name | |
| Last name | Tsukimoto |
Organization
Kanagawa dental university
Division name
Department of dental anesthesiology
Zip code
238-8570
Address
1-23, Ogawa-cho, Yokosuka, Kanagawa
TEL
046-822-8810
Homepage URL
https://www.kdu.ac.jp/hospital/department/dental/anesthesiology/
tsukimoto@kdu.ac.jp
Sponsor or person
Institute
Kanagawa Dental University
Institute
Department
Personal name
Funding Source
Organization
Japan Society for the Promotion of Science
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanagawad Dental University
Address
82, Inaoka-cho, Yokosuka, Kanagawa, Japan
Tel
046-822-8810
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
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 16 | 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
Enrolling by invitation
Date of protocol fixation
| 2024 | Year | 06 | Month | 14 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 14 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 16 | Day |
Last follow-up date
| 2031 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 08 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000062812
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
