Lemborexant Use for Cognition Improvement in Postoperative Delirium in Elderly Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 992
- 主要终点
- The incidence of POD
研究概览
简要总结
This prospective, randomized controlled trial aims to investigate the perioperative use of lemborexant, an orexin receptor antagonist, for reducing postoperative delirium (POD) in elderly patients undergoing general anesthesia.
详细描述
Patients in the intervention group will receive lemborexant, while those in the control group will receive a matching placebo. The primary outcome is the incidence of POD within 5 days after surgery. Secondary outcomes include sleep quality on postoperative days 1, 3, and 5, delirium severity and subtype, hospital anxiety and depression scores, quality of emergence from anesthesia, adverse events, and hematological parameters. The expected findings will provide evidence on the safety and efficacy of prophylactic perioperative lemborexant in improving postoperative outcomes in older patients, and will offer a theoretical and practical foundation for future research and clinical application.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60 years old;
- •ASA classification I to III;
- •Patients undergoing elective surgery;
- •Sign the informed consent form.
排除标准
- •Tracheal intubation is expected to be retained after the operation;
- •Previous history of alcohol or drug abuse;
- •Severe abnormalities in liver and kidney functions;
- •Long-term use of sedative-hypnotic drugs;
- •Severe sleep apnea and COPD;
- •Inability to cooperate in mental state;
- •Craniocerebral surgery
- •Pregnant and lactating patients;
- •Use drugs that affect orexin metabolism.
研究组 & 干预措施
The intervention group
干预措施: Lemborexant Pill (Drug)
The control group
干预措施: Placebo tablet (Drug)
结局指标
主要结局
The incidence of POD
时间窗: The 1st to 5th day after the operation
The incidence of POD within 5 days after surgery
次要结局
- Postoperative sleep quality(On the 1st, 3rd and 5th days after the operation)
- Postoperative sleep quality（The Richards-Campbell Sleep Questionnaire）(On the 1st, 3rd and 5th days after the operation)
研究者
Ruquan Han
Principal Investigator
Beijing Tiantan Hospital