The Effect of a Single Low Dose of Esketamine During Surgical Abortion in Patients With Sleep Disturbance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 1
- 主要终点
- The incidence of sleep disturbance on the first night after surgery
研究概览
简要总结
To explore the efficacy of a single low dose of esketamine during surgical abortion in patients with sleep disturbance
详细描述
Sleep disturbance occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities. Women who requires surgical abortion due to fetal anomaly or unwanted pregnancy often experience sleep disturbance. Severe sleep disturbance is a strong indicator for postoperative sleep disorders, which can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative pain, and delay postoperative recovery.
Esketamine is an N-methyl-D-aspartate(NMDA) receptor antagonist with analgesic and sedative effects, and is widely used in clinical treatment of refractory depression. For patients undergoing surgical abortion, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on sleep disturbance is worth exploring.
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18 years or older with sleep disturbance;
- •American Society of Anesthesiologists physical status I-III;
- •A gestational age below 12 weeks;
- •Elective surgery is proposed;
- •BMI of 19-30 kg/m2;
- •Patients who agreed to enroll in this study voluntarily
排除标准
- •Any contraindications to ketamine or esketamine;
- •Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- •Respiratory insufficiency, respiratory failure;
- •Bronchial asthma, severe hypertension, severe hepatic and renal dysfunction, severe cardiovascular disease, or hyperthyroidism;
- •BMI<18 kg/m2 or BMI>30kg/m2;
- •Poor compliance, unable to complete the experiment according to the study plan; Participants who have participated in clinical trials of other drugs within the last 4 weeks;
- •Any circumstances deemed unsuitable for inclusion by the researcher for any reason.
研究组 & 干预措施
Placebo Group of patients undergoing surgical abortion with normal saline
Patients undergoing surgical abortion received a single injection of 5ml 0.9% normal saline after the beginning of surgery
干预措施: normal saline (Drug)
Group of patients undergoing surgical abortion with esketamine
Patients undergoing surgical abortion received a single injection of 0.2mg/kg esketamine after the beginning of surgery
干预措施: Esketamine (Drug)
结局指标
主要结局
The incidence of sleep disturbance on the first night after surgery
时间窗: the first night after surgery
Patients completed the sleep quality scale (AIS, Athens Insomnia Scale) on the first night after surgery. The AIS has a total of 8 items,with scores ranging from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia.We asked the patients to fill out this questionnaire after the first postoperative night to evaluate the changes in sleep quality. We recorded AIS scores as statistical indicators.
次要结局
- The incidence of sleep disturbance on the seventh postoperative nights(the seventh night after surgery)
- Postoperative depression(1 day before surgery, 1, 2, 3 and 7 days after surgery)
- Pain intensity(1 hour after surgery, 1, 2, 3 and 7 days after surgery)
- Adverse event(Within 1 hour after surgery, within 1 day after surgery)
- preoperative hemoglobin concentration(the day before surgery)
- The incidence of sleep disturbance on the second and third postoperative nights(the second and third nights after surgery)
- Postoperative anxiety(1 day before surgery, 1, 2, 3 and 7 days after surgery)
- Human Chorionic Gonadotropin level(within one week before surgery, within one week after surgery)
- The incidence of sleep disturbance on the day before surgery(the day before surgery)
- The incidence of sleep disturbance before surgery(the day before surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital