Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059160) titled 'A study of the relationship between airway and stress during dental sedation' on Oct. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - KANAGAWA DENTAL UNIVERSITY

Condition: Condition - Dental Anesthesiology Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - One of the adverse events in sedation is obstruction of the airway and consequent hypoxemia. Nasopharyngeal tube is one of the ways to improve patency of the airway. This study evaluates the effects of airway obstruction during sedation and changes in patency of the airway induced by nasopharyngeal tube on tissue blood flow, tissue oxygenation, and stress. Basic objectives2 - Others

Intervention: Interventions/Control_1 - This study is a Cohot study in which the same subjects were sedated and each parameter was measured before and after the use of a nasopharyngeal tube.

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - Healthy adults (1 or 2 in the American Society of Anaesthesiologists' Classification of Systemic Conditions (ASA-PS classification)) Key exclusion criteria - 1) If there is habitual mouth breathing or if the patient is reported to be prone to epistaxis 2) Inflammation or tumour of the nasal cavity, suspected skull base fracture 3) If there is a history of chronic obstructive pulmonary disease (COPD) 4) If allergic to any of the drugs used (Propofol, Midazolam, Flumazenil) 5) If the EEG cannot be measured accurately, e.g. history of epilepsy 6) If the patient is taking antithrombotic or anticoagulant medication 7) If the patient is unable to comply with the no eating or drinking times (no food: 6 hours before the procedure No water: 3 hours before the procedure) 8) If consent to participate in the study cannot be obtained 9) If the principal investigator considers the patient to be unsuitable for participation in the study Target Size - 20

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 04 Month 01 Day Anticipated trial start date - 2025 Year 10 Month 01 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=R000065996

Disclaimer: Curated by HT Syndication.