A Randomized, Double-blind, Placebo-controlled Pilot Trial Evaluating the Effect of Tropisetron on Prevention of Postoperative Cognitive Dysfunction in Patients After Cardiac Surgery
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- The feasibility of tropisetron intervention on POCD in patients after cardiac surgery
研究概览
简要总结
The purpose of this study is to assess the feasibility of a randomized, double-blind, placebo-controlled pilot trial evaluating the effect of tropisetron on prevention of postoperative cognitive dysfunction in patients after cardiac surgery.
详细描述
Postoperative cognitive dysfunction is a common complication during postoperative period，especially in elderly patients. It is characterized by cognitive decline, inattention and abnormal mental status following surgery. The presence of postoperative cognitive dysfunction is independently associated with poor recovery, increased hospital length of stay 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.
We have designed a randomized, double-blind, placebo-controlled trial to determine if tropisetron has a positive effect on postoperative coginitive function in patients after cardiac surgery. Several assessements which are related to delirium, cognitive function, sleep and functional status, blood sample collection and EEG recordings will be involved in the trial. Moreover, we have assumed a few long-term follow-ups.
Given the complexity of the trial, we have decided to implement a pilot trial to assess the feasibility and provide vital data for future formal trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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 coronary artery bypass graft surgery under general anesthesia
- •ASA Physical Score I-IV
排除标准
- •Inability to give informed consent.
- •Contraindications to tropisetron.
- •Critical preoperative state, including preoperative left ventricular ejection fraction less than 30%, ventricular tachycardia or ventricular fibrillation, preoperative cardiopulmonary resuscitation, preoperative intra-aortic balloon pump (IABP) or mechanical circulatory requirement.
- •History of neuropsychiatric diseases (such as dementia, epilepsy, Parkinson's disease, or schizophrenia).
- •History of antipsychotic drug use.
- •Pre-existing severe cognitive impairment at baseline, defined as a Montreal Cognitive Assessment (MoCA) score below 10
研究组 & 干预措施
Tropisetron
Patients allocated to this arm will receive intravenous Tropisetron (5mg) before anesthesia induction and once daily for 7 days after surgery.
干预措施: Tropisetron (Drug)
Placebo
Patients allocated to this arm will receive an identical volume of normal saline before anesthesia and once daily for 7 days after surgery.
干预措施: Placebos (Drug)
结局指标
主要结局
The feasibility of tropisetron intervention on POCD in patients after cardiac surgery
时间窗: Within 30 days after surgery
The feasibility will mainly be determined by the percentage of participants who completed the whole study procedure from recruitment to the 1-month follow-up.
次要结局
- Length of Hospital stay(From the date of admission until discharged from hospital, up to 30 days)
- Inflammatory biomarkers(Within 7 days after surgery)
- Length of ICU stay(From the date of admission until discharged from ICU, up to 30 days)
- Sleep Quality(Within 30 days after surgery)
- Incidence of postoperative cognitive dysfunction(One day before surgery, discharge from hospital and 1 month after surgery)
- Incidence of postoperative delirium(Within 7 days after surgery)
- Functional status measurement(One day before surgery and 1 month after surgery)
- EEG frequency spectrum(Within 3 days after surgery)
- Postoperative Pain(Within 7 days after surgery)
- Incidence of postoperative nausea and vomiting(Within 7 days after surgery)
- Incidence of major adverse cardiac and cerebral events(Within 30 days after surgery)
研究者
Anshi Wu
Head of Anesthesiology
Beijing Chao Yang Hospital