The Efficacy and Safety of Tropisetron in Preventing Emergence Delirium: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 1,508
- 试验地点
- 1
- 主要终点
- Incidence of emergence delirium
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of Tropisetron in preventing emergence delirium.
详细描述
Delirium is a common complication during postoperative period, especially in elderly patients. The presence of postoperative delirium is independently associated with poor recovery, increased length of hospital stay, the development of long-term cognitive decline and increased mortality.
Tropisetron is a 5-HT3A receptor antagonist and is widely used to treat postoperative nausea and vomiting. Previous studies found that tropisetron has positive effect on cognitive function. This study aims to access the efficacy and safety of tropisetron in preventing emergence delirium.
To explore the results differences amongst different patients, subgroup analysis will be conducted according to: a. Age (older than 65 years versus 65 years or younger); b. Surgery type (major surgery versus minor surgery); c. Preoperative MoCA scores (>26 versus 18-26 versus 10-17).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Care Provider)
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
- •Written consent given
- •Scheduled to undergo elective non-cardiac surgeries under general anesthesia
- •ASA Physical Score I-III
排除标准
- •Patients with a history of neurological disease, such as Alzheimer disease.
- •Patients with a history of psychiatric disease
- •Patients with a medication history of antipsychotic drugs over the last 30 days prior to enrollment.
- •Unable to complete neuropsychological testing including patients with severe visual or hearing impairment.
- •the Montreal Cognitive Assessment (MoCA) scores below 10
- •Patients who have severe intraoperative adverse events, such as cardiac arrest.
- •Patients with contraindication of tropisetron.
研究组 & 干预措施
Tropisetron
Patients allocated to this arm will receive single dose of intravenous Tropisetron (5mg) before anesthesia induction.
干预措施: Tropisetron (Drug)
Placebo
Patients allocated to this arm will receive an identical volume of saline solution before anesthesia induction.
干预措施: Placebos (Drug)
结局指标
主要结局
Incidence of emergence delirium
时间窗: Until the end of post-anesthesia care unit stay, assessed up to 1 hour
Screening of the patients regarding an emergence delirium by The Confusion Assessment Method for The Intensive Care Unit (CAM-ICU). CAM-ICU is assessed at three different points of time: 1. 15min after excubation 2. 30min after excubation 3. At discharge from post-anesthesia care unit (PACU)
次要结局
- Incidence of postoperative delirium(Within 3 days after surgery)
- Incidence of postoperative nausea and vomiting(Within 3 days after surgery)
- Postoperative Pain(Within 3 days after surgery)
- Length of Hospital stay(From the date of admission until discharged from hospital, up to 30 days)
- Adverse events(Within 3 days after surgery)
研究者
Anshi Wu
Head of Anesthesiology
Beijing Chao Yang Hospital