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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy
Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy
Fu Jen Catholic University Hosptial
New Taipei City, Taiwan (r.o.c.), Taiwan
Apneic events
Apnea event during sedation
Time frame: from start of sedation to outpatient discharge from postoperative care unit
Bradycardia
Heart rate less than 60 beats per minute during sedation
Time frame: from start of sedation to outpatient discharge from postoperative care unit
Hypotension
Hypotensive event (defined as less mean blood pressure less than 80% of preoperative mean blood pressure) during sedation
Time frame: from start of sedation to outpatient discharge from postoperative care unit
Agitation
Agitation, coughing, involuntary movement during sedation
Time frame: from start of sedation to outpatient discharge from postoperative care unit
Surgeon satisfaction score
Rate of surgeon satisfaction of certain sedation
Time frame: From start of sedation to outpatient discharge from postoperative care unit
Hypoxic event
hypoxic event during sedation
Time frame: From start of sedation to outpatient discharge from postoperative care unit
Top-up requirement
Additional sedative agents given during sedation
Time frame: From start of sedation to outpatient discharge from postoperative care unit
Patient satisfaction score
validated questionnaire regarding anesthesia quality in chinese after sedation for patients
Time frame: Before outpatient discharge from postoperative care unit
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