Effect of Esketamine Combined With Remimazolam on Postoperative Sleep Disturbance and Anxiety in Patients Undergoing Gastroenteroscopies
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Sleep disturbance and anxiety after surgery
研究概览
简要总结
To explore the effects of esketamine combined with remimazolam on postoperative sleep disturbance and anxiety in surgical patients undergoing gastroenteroscopies
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 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 and anxiety 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20-65 years old;
- •ASA classification 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;
- •ASA rating of IV or V;
- •Coronary heart disease, bronchial asthma, severe hypertension, severe blood system dysfunction, liver and kidney function, electrolyte abnormalities;
- •History of gastrointestinal disease (peptic ulcer, Crohn's disease, ulcerative colitis);
- •Respiratory insufficiency, respiratory failure;
- •Patients who refused to use intravenous PCA for analgesia;
- •Pregnant or lactating women;
- •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
Group of patients undergoing gastroenteroscopies with normal saline
Patients undergoing gastroenteroscopies were given propofol 2-3mg/kg and 10ml 0.9% saline before the procedure began
干预措施: normal saline (Drug)
Group of patients undergoing gastroenteroscopies with esketamine
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and esketamine 0.2mg/kg before the procedure began
干预措施: Esketamine (Drug)
Group of patients undergoing gastroenteroscopies with remimazolam
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg and remimazolam 0.15mg/kg before the procedure began
干预措施: Remimazolam (Drug)
Group of patients undergoing gastroenteroscopies with remimazolam and esketamine
Patients undergoing gastroenteroscopies were given propofol 2 to 3mg/kg， esketamine 0.2mg/kg and remimazolam 0.15mg/kg before the procedure began
干预措施: Esketamine and remimazolam (Drug)
结局指标
主要结局
Sleep disturbance and anxiety after surgery
时间窗: 1 day before surgery, 1 and 3 days after surgery
Patients completed the sleep quality (AIS, Athens Insomnia Scale) and anxiety (Hospital Anxiety and Depression Scale) rating scales on the day before surgery. HADS consists of 14 items to calculate the patient's comprehensive score, including 7 anxiety related scores and 7 depression related scores. Each question in the questionnaire was scored on a scale of 0-3, so patients scored 0-21 on both anxiety and depression. Scores of 8 points or higher are diagnosed as depression or anxiety.And we asked the patients to fill out these questionnaires on the day 1 and 3 after surgery again to evaluate the changes in sleep quality and anxiety. (The AIS score ranges from 0 to 24 points, and a total score of 6 points or higher indicates a diagnosis of insomnia). . We recorded AIS scores, HDS-A scores and HDS-D scores as separate statistical indicators.
次要结局
- Mean intraoperative blood pressure(Intraoperative)
- Oxygen saturation(Intraoperative)
- Pain Score (NRS)(1 and 3 days after surgery)
- Incidence of injection pain(Intraoperative)
- Dosage of drug(Intraoperative)
- Somatokinetic reaction(Intraoperative)
- Operation time(Intraoperative)
- Duration of anesthesia(After surgery)
- Time of awakening(After surgery)
- Time to walking down(After surgery)
- Adverse event(Within 3 days after surgery)
- Exhaust time(Within 3 days after surgery)
研究者
Guolin Wang
Professor
Tianjin Medical University General Hospital