NCT06531915尚未招募不适用
Comparison of Efficacy and Safety Between Ciprofol and Remimazolam During Fiberoptic Bronchoscopy: a Study Protocol for a Single-center, Double-blind, Randomized Controlled Trial
Anhui Provincial Hospital0 个研究点目标入组 190 人开始时间: 2024年12月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 190
- 主要终点
- The success rate of fiberoptic bronchoscopy
研究概览
简要总结
Both ciprofol and remimazolam have been found to be potential alternatives to propofol (a commonly used anesthesia) during fiberoptic bronchoscopy, while the efficacy and safety between ciprofol and remimazolam have not been reported. This study aims to compare the efficacy and safety between ciprofol and remimazolam in patients undergoing fiberoptic bronchoscopy.
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
- Double (Participant, 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
- •male or female patients with age ≥ 18 years old;
- •scheduled to undergo bronchoscopy under laryngeal mask airway;
- •with American Society of Anesthesiologists (ASA) physical status classes II to Ⅲ; and
- •volunteering to participate in this study and signing an informed consent form.
排除标准
- •with contraindications to deep sedation/general anesthesia or with a history of sedation/anesthesia accidents;
- •allergic to eggs, bean products, or experimental drugs (ciprofol, sufentanil, or remimazolam);
- •difficult airway;
- •with bradycardia or other serious cardiovascular diseases;
- •with severe damages or diseases in important organs such as the lungs, brain, liver, or kidneys;
- •using sedatives or antidepressants for a long time;
- •pregnant or lactating women; and (8) unable to communicate or cooperate.
研究组 & 干预措施
Ciprofol group
Experimental
干预措施: Ciprofol (Drug)
Remimazolam group
Active Comparator
干预措施: Remimazolam (Drug)
结局指标
主要结局
The success rate of fiberoptic bronchoscopy
时间窗: 24 hours after fiberoptic bronchoscopy
次要结局
- Recovery time(24 hours after fiberoptic bronchoscopy)
- Doses of experimental drugs (ciprofol or remimazolam)(24 hours after fiberoptic bronchoscopy)
- Stay time in PACU(24 hours after fiberoptic bronchoscopy)
- Diastolic blood pressure(6 minutes after fiberoptic bronchoscopy)
- SpO2(6 minutes after fiberoptic bronchoscopy)
- Procedure time(24 hours after fiberoptic bronchoscopy)
- Awake time(24 hours after fiberoptic bronchoscopy)
- Times of using rescue sedative drug(24 hours after fiberoptic bronchoscopy)
- Incidence of adverse events(24 hours after fiberoptic bronchoscopy)
- Patients' satisfaction(24 hours after fiberoptic bronchoscopy)
- Heart rate(6 minutes after fiberoptic bronchoscopy)
- Induction time(24 hours after fiberoptic bronchoscopy)
- Supplemental times of experimental drugs (ciprofol or remimazolam)(24 hours after fiberoptic bronchoscopy)
- Doses of using rescue sedative drug(24 hours after fiberoptic bronchoscopy)
- SBP(6 minutes after fiberoptic bronchoscopy)
研究者
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