Tokyo, Dec. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059877) titled 'Profile of Temperature under Sedation Study' on Dec. 1.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Nagasaki University

Condition: Condition - The study will include patients scheduled for dental treatment under intravenous sedation who fulfill at least one predefined inclusion criterion, do not meet any exclusion criteria, and for whom written informed consent is obtained from the patient or a legally authorized representative. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To describe body temperature changes in patients receiving dental treatment with intravenous sedation. Basic objectives2 - Others

Intervention: Interventions/Control_1 - Non-invasive tympanic temperature measurement will be performed using a standard ear thermometer within routine clinical care.

Eligibility: Age-lower limit - Not applicable Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Patients scheduled to undergo dental treatment under intravenous sedation who meet at least one of the following criteria and provide written informed consent (patient or legally authorized representative): 1. Adult patients (>=18 years) with decision-making capacity who provide written informed consent 2. Adult patients (>=18 years) without decision-making capacity whose legally authorized representative provides written informed consent 3. Minor patients (<18 years) judged to lack decision-making capacity whose legally authorized representative provides written informed consent Key exclusion criteria - Patients will be excluded if they meet any of the following criteria: 1. Patients for whom tympanic temperature measurement with an ear thermometer is judged to be difficult or inappropriate 2. Patients with external ear conditions that may affect tympanic temperature measurement (e.g., otitis externa, tympanic membrane injury) 3. Patients judged by the principal investigator to be unsuitable for participation in this study Target Size - 42

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 11 Month 25 Day Anticipated trial start date - 2025 Year 12 Month 01 Day Last follow-up date - 2028 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068418

Disclaimer: Curated by HT Syndication.