NCT07017283招募中不适用
Effect of Deep Analgosedation vs. Endotracheal Intubation General Anesthesia on Perioperative Respiratory Adverse Events in Elderly ERCP Patients: An Open-Label Randomized Controlled Trial
Gang Chen1 个研究点 分布在 1 个国家目标入组 170 人开始时间: 2025年11月10日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 170
- 试验地点
- 1
- 主要终点
- Perioperative sedation related adverse events
研究概览
简要总结
This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.
详细描述
This study aims to investigate the impact of deep analgosedation versus endotracheal intubation general anesthesia on perioperative sedation related adverse events in elderly ERCP patients.
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
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 60 and above;
- •ASA physical status≤III;
- •Patients who scheduled for elective therapeutic ERCP (ERCP complexity grading system;
- •Willing to provide informed consent (or by legal guardian/witness if applicable).
排除标准
- •1: Altered gastrointestinal anatomy, delayed gastric emptying, or gastric outlet obstruction； 2.Coagulopathy or epistaxis tendency; 3.Cardiac diseases (e.g., coronary artery disease, heart failure, arrhythmias); 4.Pulmonary diseases (e.g., asthma, COPD); 5.Prior hypersensitivity to anesthetic agents; 6.Active upper respiratory infection； 7.Severe liver and kidney diseases； 8.Difficult airway: Preoperative anesthesiologist assessment of difficult airway； 9.Psychiatric disorders, cognitive impairment, critical illness, or pregnancy.
研究组 & 干预措施
General anesthesia
Active Comparator
干预措施: Tracheal intubation general anesthesia (Device)
Deep sedation
Experimental
干预措施: Nasopharyngeal airway ventilation (Device)
结局指标
主要结局
Perioperative sedation related adverse events
时间窗: Perioperative period
次要结局
- patient/endoscopist satisfaction(Perioperative)
- hospital stay duration(Perioperative)
- recovery room time(Perioperative period)
- Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation(Perioperative)
- Second intubation after the tracheal intubation is removed(Perioperative)
- Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute)(Perioperative)
- Rating of reflux degree(perioperative)
- QoR-15 score on POD1(Postoperative day 1)
- respiratory failure/ARDS incidence(Perioperative)
- recovery room time(Perioperative period)
- Nasopharyngeal airway requires face mask ventilation or switching to tracheal intubation(Perioperative)
- Second intubation after the tracheal intubation is removed(Perioperative)
- Tachycardia (>100 beats/minute) or bradycardia (<50 beats/minute)(Perioperative)
- Rating of reflux degree(perioperative)
- QoR-15 score on POD1(Postoperative day 1)
- Incidence of postoperative nausea and vomiting(postoperative day 1)
- respiratory failure/ARDS incidence(Perioperative)
- Postoperative cognitive function assessment (MoCA)(Perioperative)
- patient/endoscopist satisfaction(Perioperative)
- hospital stay duration(Perioperative)
研究者
Gang Chen
chief physician
Sir Run Run Shaw Hospital
研究点 (1)
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