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Not Yet Recruiting NCT07459322

The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy

Conditions: OSAS (Obstructive Sleep Apneas Syndrome), DISE, Sedation

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Fu Jen Catholic University Hospital

Location: Fu Jen Catholic University Hosptial New Taipei City Taiwan (r.o.c.)

Summary

This study seeks to compare the clinical efficacy and safety of the novel sedative Remimazolam with Dexmedetomidine in Drug-Induced Sleep Endoscopy (DISE), evaluating their performance in sedation depth stability, incidence of adverse events, and postoperative recovery time, thereby providing evidence-based guidance for sedative selection in OSA patients. Additionally, it aims to develop a model for predicting upper airway obstruction sites by analyzing Polysomnography (PSG) data with artificial intelligence, enhancing diagnostic accuracy and treatment decision-making efficiency for Obstructive Sleep Apnea (OSA) to optimize clinical management.

Eligibility Criteria

Inclusion Criteria: * Patients age \> 18 years old * American Society of Ansthesiologists functional class \< III * Schedule to receive DISE exam for evaluation of OSAS Exclusion Criteria: * Patient refusal * Allergic to experimental medication * History of central nervous system diseases * History of psychiatric diseases * Pregnancy * Severe, uncontrolled systemic diseases

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07459322). StuddyBuddy aggregates publicly available trial information.