UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000051146 |
|---|---|
| Receipt number | R000058326 |
| Scientific Title | Effect of propofol on salivary secretion from the submandibular, sublingual, and labial glands during intravenous sedation. |
| Date of disclosure of the study information | 2023/05/23 |
| Last modified on | 2023/05/23 19:47:04 |
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Basic information
Public title
Effect of propofol on salivary secretion from the submandibular, sublingual, and labial glands during intravenous sedation.
Acronym
Effect of propofol on salivary secretion from the submandibular, sublingual, and labial glands during intravenous sedation.
Scientific Title
Effect of propofol on salivary secretion from the submandibular, sublingual, and labial glands during intravenous sedation.
Scientific Title:Acronym
Effect of propofol on salivary secretion from the submandibular, sublingual, and labial glands during intravenous sedation.
Region
| Japan |
Condition
Condition
Dental phobia
Classification by specialty
| Anesthesiology | Dental medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Recent animal studies have suggested the role of GABA type A (GABA-A) receptors in salivation, showing that GABA-A receptor agonists inhibit salivary secretion. This study aimed to evaluate the effects of propofol (a GABA-A agonist) on salivary secretions from the submandibular, sublingual, and labial glands during intravenous sedation in healthy volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Salivary flow rates in the submandibular, sublingual glands, and the labial glands
Key secondary outcomes
Mean blood pressure, pulse rate, and sedation level
Amylase activity in the saliva from the submandibular and sublingual glands
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
An intravenous catheter was inserted into the median cubital vein, and lactated Ringer's solution was infused at 2 mL/kg/h. The participants were placed in a sitting position on a dental chair for 20 min. After confirming that the cardiovascular parameters were in a steady state, the participants were sedated with propofol (a loading dose of 6 mg/kg/h for 10 min and a continuous infusion dose of 3 mg/kg/h for 15 min).
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
| 22 | years-old | <= |
Age-upper limit
| 43 | years-old | >= |
Gender
Male
Key inclusion criteria
Participants were categorized according to the American Society of Anesthesiologists physical status 1,
Key exclusion criteria
Exclusion criteria was subject except for Anesthesiologists physical status 1.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Kawaai |
Organization
Ohu University School of Dentistry
Division name
Department of Oral Function and Molecular Biology
Zip code
963-8611
Address
31-1 Misumido, Tomita, Koriyama, Fukushima
TEL
0249329337
maromaro@ce.mbn.or.jp
Public contact
Name of contact person
| 1st name | Hiroyoshi |
| Middle name | |
| Last name | Kawaai |
Organization
Ohu University School of Dentistry
Division name
Department of Oral Function and Molecular Biology
Zip code
963-8611
Address
31-1 Misumido, Tomita, Koriyama, Fukushima
TEL
0249329337
Homepage URL
maromaro@ce.mbn.or.jp
Sponsor or person
Institute
Ohu University
Institute
Department
Personal name
Funding Source
Organization
Department of Oral Function and Molecular Biology, School of Dentistry, Ohu University.
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Ethics Committee of Ohu University
Address
31-1 Misumido, Tomita, Koriyama, Fukushima
Tel
0249328931
h-kawai@den.ohu-u.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
| 2023 | Year | 05 | Month | 23 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
20
Results
We found that the salivary flow rates in the submandibular, sublingual, and labial glands significantly decreased during intravenous sedation with propofol (P < 0.01). Similarly, amylase activity in the saliva from the submandibular and sublingual glands was significantly decreased (P < 0.01).
Results date posted
| 2023 | Year | 05 | Month | 23 | Day |
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
| 2017 | Year | 06 | Month | 15 | Day |
Date of IRB
| 2017 | Year | 06 | Month | 15 | Day |
Anticipated trial start date
| 2017 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2023 | 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
| 2023 | Year | 05 | Month | 23 | Day |
Last modified on
| 2023 | Year | 05 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000058326
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