UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058373 |
|---|---|
| Receipt number | R000066734 |
| Scientific Title | The effects of sedatives on nociceptive responses during dental surgery with sedation: A pilot study comparing dexmedetomidine and propofol on intra-operative and postoperative pain and short-term outcomes |
| Date of disclosure of the study information | 2025/07/07 |
| Last modified on | 2025/07/05 11:57:00 |
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Basic information
Public title
A study comparing two sedatives to reduce pain during dental surgery
Acronym
Tooth Extraction and Sedative Effects Study
Scientific Title
The effects of sedatives on nociceptive responses during dental surgery with sedation: A pilot study comparing dexmedetomidine and propofol on intra-operative and postoperative pain and short-term outcomes
Scientific Title:Acronym
Dental Surgery Sedative Impact Study
Region
| Japan |
Condition
Condition
Individuals who undergo third molar extraction under sedation management at the Department of Dental Anesthesiology, Hokkaido University Hospital between the date of study approval and March 31, 2026, and who are hospitalized postoperatively.
Classification by specialty
| Anesthesiology | Dental medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of continuous administration of dexmedetomidine or propofol on the suppression of nociceptive stimuli, including pain.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Temporal changes in the High Frequency Variability Index (HFVI) and comparison between dexmedetomidine and propofol
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | < |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1 Individuals aged 18 years or older at the time of consent.
2 Individuals classified as ASA Physical Status 1 or 2.
3 Individuals with a BMI between 18.5 and 25.
4 Individuals scheduled to undergo third molar extraction under intravenous sedation, with an expected surgical duration of more than 30 minutes.
5 Individuals scheduled to receive 2% lidocaine with epinephrine as the local anesthetic during infiltration anesthesia.
6 Individuals scheduled to be managed under intravenous sedation using either dexmedetomidine or propofol.
7 Individuals scheduled to receive intravenous flurbiprofen axetil at the end of anesthesia as postoperative analgesia.
8 Individuals who have received a full explanation of the study, fully understood its content, and provided written informed consent of their own free will.
Key exclusion criteria
1 Individuals taking steroids or immunosuppressive agents at the time of the preoperative examination.
2 Individuals with a maximal mouth opening of three fingerbreadths or less.
3 Individuals deemed unsuitable for participation in the study by the principal investigator for any other reason.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Yukie |
| Middle name | |
| Last name | Nitta |
Organization
Hokkaido University Hospital
Division name
Dental Anesthesiology
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido
TEL
011-706-4336
nitta@den.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Yukie |
| Middle name | |
| Last name | Nitta |
Organization
Hokkaido University Hospital
Division name
Dental Anesthesiology
Zip code
060-8648
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido
TEL
011-706-4336
Homepage URL
nitta@den.hokudai.ac.jp
Sponsor or person
Institute
Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
None
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
Ethical Review Board for Life Science and Medical Research, Hokkaido University Hospital
Address
Kita14, Nishi5, Kita-Ku, Sapporo Hokkaido
Tel
011-706-7636
crjimu@huhp.hokudai.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
| 2025 | Year | 07 | Month | 07 | 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
| 2024 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 25 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 08 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The project is approximately 70% complete at this point.
Management information
Registered date
| 2025 | Year | 07 | Month | 05 | Day |
Last modified on
| 2025 | Year | 07 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066734
