The Use of Remimazolam Versus Dexmedetomidine for Patients Receiving Drug-Induced Sleep Endoscopy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Apneic events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients age > 18 years old
- •American Society of Ansthesiologists functional class < III
- •Schedule to receive DISE exam for evaluation of OSAS
排除标准
- •Patient refusal
- •Allergic to experimental medication
- •History of central nervous system diseases
- •History of psychiatric diseases
- •Pregnancy
- •Severe, uncontrolled systemic diseases
研究组 & 干预措施
Patients with OSAS receiving remimazolam for sedation during DISE
Patients with obsturctive sleep apne syndrome receiving remimazolam for sedation during drug-induced sleep endoscopy
干预措施: 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
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Apneic events
时间窗: from start of sedation to outpatient discharge from postoperative care unit
Apnea event during sedation
Bradycardia
时间窗: from start of sedation to outpatient discharge from postoperative care unit
Heart rate less than 60 beats per minute during sedation
Hypotension
时间窗: 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
时间窗: from start of sedation to outpatient discharge from postoperative care unit
Agitation, coughing, involuntary movement during sedation
Surgeon satisfaction score
时间窗: From start of sedation to outpatient discharge from postoperative care unit
Rate of surgeon satisfaction of certain sedation
Hypoxic event
时间窗: From start of sedation to outpatient discharge from postoperative care unit
hypoxic event during sedation
次要结局
- 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)