NCT06784479进行中（未招募）4 期
A Randomized Clinical Trial to Evaluate the Sedative Effect of the Combination of Remimazolam and Propofol in Drug-induced Sleep Endoscopy
Dan Liu1 个研究点 分布在 1 个国家目标入组 174 人开始时间: 2025年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 174
- 试验地点
- 1
- 主要终点
- sedation success rate
研究概览
简要总结
This study helps patients find the optimal sedation regimen in drug-induced sleep endoscopy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients diagnosed with sleep apnea hypopnea syndrome were included
排除标准
- •Patients were excluded if they had nasal obstruction, significantly deviated nasal septum, nasal turbinate hypertrophy, or nasal polyps. Patients with uncontrolled heart failure, renal insufficiency, diabetes, or hyperthyroidism were also excluded. Patients were also excluded if taking medications that could affect upper airway muscle function, such as ben- zodiazepines and muscle relaxants.
研究组 & 干预措施
Application of remimazolam and propofol to achieve satisfactory sedative effect
Experimental
干预措施: Remimazolam and Propofol (Drug)
Application of propofol to achieve satisfactory sedative effect
Active Comparator
干预措施: Propofol (Drug)
Application of midazolam and propofol to achieve satisfactory sedative effect
Active Comparator
干预措施: Midazolam and propofol (Drug)
结局指标
主要结局
sedation success rate
时间窗: During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient)
a composite measure including completion of the DISE, no requirement for rescue sedative medication, and no requirement for more than 5 top-up doses of the trial medication after the initial dose.
次要结局
- Procedure-related adverse effect-The need for antidote administration(During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient))
- Procedure-related adverse effect-The occurrence of tachycardia(During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient))
- Procedure-related adverse effect-The occurrence of hypotension(During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient))
- Procedure-related adverse effect-The occurrence of hypoxemia(During procedure (From the start of drug induced sleep endoscopy to the complete awakening of the patient))
- The degree of patient and physician satisfaction(During procedure (the start of drug induced sleep endoscopy to the complete awakening of the patient))
- Sedative effect-Adequate sedation time(During procedure (From the start of medication to target BIS range), an average of 2min)
- Sedative effect-sedation to recovery time(The time period of the end of operation to complete wakefulness,through operation completion, an average of 30min)
研究者
Dan Liu
Master of Medicine, attending physician
Tianjin Medical University General Hospital
研究点 (1)
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