Tokyo, July 7 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058373) titled 'A study comparing two sedatives to reduce pain during dental surgery' on July 7.
Study Type:
Observational
Primary Sponsor:
Institute - Hokkaido University Hospital
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 malignancy - Others
Genomic information - NO
Objective:
Narrative objectives1 - To evaluate the effects of continuous administration of dexmedetomidine or propofol on the suppression of nociceptive stimuli, including pain.
Basic objectives2 - Efficacy
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 Size - 30
Recruitment Status:
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
To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066734
Disclaimer: Curated by HT Syndication.
