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

Condition(s) studied

Investigational drug(s) / intervention(s)

Remimazolam: Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy

Dexmedetomidine: Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy

Study 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

Primary outcome measure(s)

• Apneic events — from start of sedation to outpatient discharge from postoperative care unit
  Apnea event during sedation
• Bradycardia — from start of sedation to outpatient discharge from postoperative care unit
  Heart rate less than 60 beats per minute during sedation
• Hypotension — from start of sedation to outpatient discharge from postoperative care unit
  Hypotensive event (defined as less mean blood pressure less than 80% of preoperative mean blood pressure) during sedation
• Agitation — from start of sedation to outpatient discharge from postoperative care unit
  Agitation, coughing, involuntary movement during sedation
• Surgeon satisfaction score — From start of sedation to outpatient discharge from postoperative care unit
  Rate of surgeon satisfaction of certain sedation
• Hypoxic event — From start of sedation to outpatient discharge from postoperative care unit
  hypoxic event during sedation

Trial sites (1)

More Fu Jen Catholic University Hospital trials in Taiwan