Esketamine vs Remimazolam for Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Oocyte Retrieval
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 315
- 试验地点
- 1
- 主要终点
- The incidence of postoperative sleep disturbance on the first night after surgery
研究概览
简要总结
To explore and compare the effects of esketamine and remimazolam on postoperative sleep disturbance in patients undergoing oocyte retrieval
详细描述
Postoperative sleep disturbance (PSD) occur in the form of sleep deprivation, circadian rhythm disturbance, and structural abnormalities, and have a high incidence in patients undergoing surgery. Postoperative sleep disorders can lead to postoperative delirium and cognitive dysfunction, aggravate postoperative acute pain, and delay postoperative recovery.
Benzodiazepines have a certain sedative hypnotic anti-anxiety effect, and remimazolam as a new benzodiazepine, its sedative hypnotic anti-anxiety effect is worthy of further exploration. 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 surgery, in addition to sedation and analgesia, whether the intraoperative use of esketamine has positive effects on postoperative 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
- Prevention
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age 18-45 years old;
- •American society of Aneshesiologists（ASA）physical status classification system is grade I-III;
- •Elective surgery is proposed
- •BMI of 19-30 kg/m2;
- •Patients who agreed to enroll in this study voluntarily
排除标准
- •Those who are known to be allergic to the drug ingredients in this study and their allergic constitution;
- •Allergic history of general anesthesia drugs, opioid drugs, non-steroidal drugs;
- •History of neurological diseases; History of chronic pain; Drug and alcohol addiction; A long history of opioid use; Opiates were given 48 hours before surgery
- •Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
- •Respiratory insufficiency, respiratory failure;
- •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;
- •Preoperative Pittsburgh Sleep Quality Index (PSQI) higher than 7
- •Any circumstances deemed unsuitable for inclusion by the researcher for any reason.
研究组 & 干预措施
Placebo Group of patients undergoing oocyte retrieval with normal saline
Patients undergoing oocyte retrieval were given 5ml 0.9% saline before anesthesia and surgery
干预措施: normal Saline (Drug)
Group of patients undergoing oocyte retrieval with esketamine
Patients undergoing oocyte retrieval were given esketamine 0.2mg/kg before anesthesia and surgery
干预措施: Esketamine (Drug)
Group of patients undergoing oocyte retrieval with remimazolam
Patients undergoing oocyte retrieval were given remimazolam 0.2mg/kg before anesthesia and surgery
干预措施: Remimazolam (Drug)
结局指标
主要结局
The incidence of postoperative 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 day 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
- Oxygen saturation(Intraoperative)
- Adverse event(Within 3 days after surgery)
- The incidence of postoperative sleep disturbance on the second and third postoperative nights(the second and third nights after surgery)
- Postoperative anxiety(1 day before surgery ,1 and 2 days after surgery)
- Operation time(Intraoperative)
- Duration of anesthesia(Intraoperative)
- The incidence of sleep disturbance one day before surgery(one day before surgery)
- Mean intraoperative blood pressure(Intraoperative)
- Somatokinetic reaction(Intraoperative)
- Time to walking down(Within1 hour after surgery)
- Postoperative depression(1 day before surgery ,1 and 2 days after surgery)
- Pain Score (NRS)(1 and 2 days after surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital