The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Apneic events
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Patients with OSAS receiving remimazolam for sedation during DISE
Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy
Intervention: Remimazolam (Drug)
Patients with OSAS receiving dexmedetomidine for sedation during DISE
Patients with obsturctive sleep apne syndrome receiving dexmedetomidine for sedation during drug-induced sleep endoscopy
Intervention: Dexmedetomidine (Drug)
Outcomes
Primary Outcomes
Apneic events
Time Frame: from start of sedation to outpatient discharge from postoperative care unit
Apnea event during sedation
Bradycardia
Time Frame: from start of sedation to outpatient discharge from postoperative care unit
Heart rate less than 60 beats per minute during sedation
Hypotension
Time Frame: 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
Time Frame: from start of sedation to outpatient discharge from postoperative care unit
Agitation, coughing, involuntary movement during sedation
Surgeon satisfaction score
Time Frame: From start of sedation to outpatient discharge from postoperative care unit
Rate of surgeon satisfaction of certain sedation
Hypoxic event
Time Frame: From start of sedation to outpatient discharge from postoperative care unit
hypoxic event during sedation
Secondary Outcomes
- VOTE classification prediction(Perioperative phase)
- Top-up requirement(From start of sedation to outpatient discharge from postoperative care unit)
- Patient satisfaction score(Before outpatient discharge from postoperative care unit)