Effect of Esketamine on Anxiety State in Patients Undergoing Abdominal Tumor Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 185
- 试验地点
- 1
- 主要终点
- Whether esketamine can reduce anxiety status in patients with anxiety
研究概览
简要总结
To evaluate whether esketamine can relieve anxiety in patients undergoing abdominal tumor surgery.
详细描述
Hamilton anxiety Scale was used to screen patients with anxiety. Only patients with score ≥ 8 were enrolled. These patients were randomly assigned to the experimental group and control group.
All patients enrolled were evaluated with Hamilton anxiety Scale, PHQ-8 scale, QoR-15 Scale and Athens Insomnia Scale. After induction, sevoflurane and remifentanil were used to maintain anesthesia. The experimental group had esketamine while the control group had normal saline. Athens Insomnia Scale was used to assess the sleep status 1, 2, 3 days after surgery and 1 month after surgery. Hamilton anxiety Scale was used to evaluate the anxiety state of the patients 3 days after surgery and 1 month after surgery. PHQ-8 scale, QoR-15 Scale were collected 3 days after surgery and 1 month after 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing abdominal tumor surgery;
- •older than 18 years old and younger than 70 years old;
- •ASA grade I-III；
- •Hamilton anxiety scale ≥ 8.
排除标准
- •Having serious mental illness before surgery or on antipsychotic medication in the two weeks before screening;
- •Severe organ function lesions such as heart failure (left ventricular ejection fraction <30%), myocardial infarction, kidney failure (requiring kidney replacement therapy), liver function impairment (Child-Pugh grade C), etc.
- •Patients arranged to receive general anesthesia combined with epidural anesthesia patients;
- •Patients who cannot communicate, read or write due to visual, auditory, language or other reasons;
- •Patients allergic to ketamine;
- •Patients refused to use postoperative self-controlled intravenous analgesia pump;
- •Patients refused to participate in the study.
研究组 & 干预措施
Experiment group
Esketamine 0.2mg/kg was given slowly after intubation, and then 0.1mg/kg/h was pumped continuously until the end of the operation. Patients received sufentanil based patient-controlled intravenous analgesia (PCIA) within 72 hours postoperatively, with sufentanil combined with esketamine 1mg/kg in a PCIA device.
干预措施: Esketamine (Drug)
Control group
Same volume of normal saline was given slowly after intubation, and then pumped continuously until the end of the operation. Patients received sufentanil based patient-controlled intravenous analgesia (PCIA) within 72 hours postoperatively, without esketamine in the PCIA device.
干预措施: normal saline (Drug)
结局指标
主要结局
Whether esketamine can reduce anxiety status in patients with anxiety
时间窗: 1 day before surgery, 3 days after surgery, 1 month after surgery
assessed by Hamilton anxiety scale. The score ranges from 0 to 56, while the higher score means a more anxious state.
次要结局
- To explore whether esketamine can improve life quality(1 day before surgery, 3 days after surgery, 1 month after surgery)
- To explore whether esketamine can improve sleep status(1 day before surgery, 1,2 and 3 days after surgery, 1 month after surgery)
研究者
Wen Zhang
attending, principle investigator
Zhejiang Cancer Hospital