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