Effect of a Single Dose of Esketamine on Perioperative Negative Mood in Patients Undergoing Cardiac Valve Surgery: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 142
- 试验地点
- 2
- 主要终点
- Perioperative anxiety and depreession
研究概览
简要总结
A multi-center, randomized controlled, blinded prospective study to investigate the effect of esketamine on perioperative anxiety and depression in patients undergoing cardiac valve surgery.
详细描述
Undergoing surgery can be a traumatic and painful experience for patients, often causing negative mood such as anxiety and depression. The size and type of surgery have a significant impact on the occurrence of anxiety and depression in patients, and approximately 1/3 of patients after cardiac surgery have anxiety or depression, which increase the risk of recurrent cardiovascular events and death. Ketamine is a type of anesthetic drug with comprehensive effects, including analgesia, sedation, and amnesia. Its primary mechanism of action is blocking N-methyl-D-aspartate (NMDA) receptors. Esketamine is the pure dextro isomer of ketamine, which has a higher affinity for glutamate NMDA receptors and opioid receptors, and has stronger sedative, analgesic, and antidepressant effects. On March 4,2019, esketamine has been licensed by the FDA for treatment-resistant depression. Given its analgesic, anesthetic and antidepressant effects, esketamine may be an ideal drug for improving negative mood in patients undergoing cardiac surgery
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
- Triple (Participant, Investigator, 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
- •Age ≥18 years old, male or female
- •Patients undergoing heart valve surgery
- •Patients with ASA grade 1 to 4
- •BMI between 18-30 kg/m²
- •Able to participate in neuropsychological testing and receive follow-up visits
- •Clearly understand and voluntarily agree to participate in the study and sign the informed consent form
排除标准
- •Patients with significant preoperative neuro-psychiatric disease and cognitive impairment
- •Intellectual disability or a MiniMental State Examination (MMSE) score <24, or a speech disorder that may compromise their ability to undergo preoperative assessments
- •History of psychoactive drug abuse
- •5. Preoperative combined severe hepatic insufficiency or renal insufficiency
- •Any contraindications to ketamine or esketamine, such as refractory hypertension or hyperthyroidism
研究组 & 干预措施
Esketamine group
Patients who undergo general anesthesia using esketamine.
干预措施: Esketamine (Drug)
Control group
Patients who undergo general anesthesia without esketamine
干预措施: normal saline (Drug)
结局指标
主要结局
Perioperative anxiety and depreession
时间窗: Preoperative day 1, postoperative day 7 and day 30
The primary outcomes were depression and anxiety, which were assessed using the Hospital Anxiety and Depression Scale (HADS). Perioperative anxiety was measured using the Hospital Anxiety and Depression Scale-Anxiety (HADS-A) subscale, a standardized self-report instrument consisting of 7 items. Patients with a HADS-A score of 8 or more were considered to be experiencing anxiety, with a score of 8 to 10 indicating mild anxiety, 11 to 14 indicating moderate anxiety, and 15 to 21 indicating severe anxiety. Perioperative depression was measured using the Hospital Anxiety and Depression Scale-Depression (HADS-D) subscale. Patients with a HADS-D score of 8 or more were considered to be experiencing depression, with a score of 8 to 10 indicating mild depression, 11 to 14 indicating moderate depression, and 15 to 21 indicating severe depression.
次要结局
- Postoperative Sleep Quality(Preoperative day 1, postoperative day 7 and day 30)
- Delirium(Within 7 days after surgery)
- PONV(Within 2 days after extubation)
- Postoperative Recovery Quality(Postoperative day 7 and day 30)
- Postoperative Pain(Postoperative day 7 and day 30)
- Postoperative Quality of Life(Postoperative day 7 and day 30)
研究者
Weidong Mi
Director (Cheif expert of National key research and development program of China 2018YFC2001900)
Chinese PLA General Hospital