Remimazolam Improves the Safety in Elderly Patients Undergoing Gastrointestinal : a Multicenter,Randomized Controlled Study
试验速览
- 阶段
- 4 期
- 入组人数
- 300
- 试验地点
- 9
- 主要终点
- Incidence of hyoxemia
研究概览
简要总结
Gastroenteroscopy diagnosis and treatment drugs need to meet the needs of quick onset, quick recovery and less anesthesia complications. Remimazolam is an anesthetic sedative independently developed by China. It is a new short-acting GABA(A) receptor agonist. Remimazolam has the advantages of rapid onset, rapid recovery, antagonist, controllable degree of cardiovascular and respiratory depression, low incidence of hypotension and respiratory depression. However, elderly patients as important and special patients, there are still a lack of relevant studies and reports.
In order to verify the safety and effectiveness of remimazolam in the gastroenteroscopy treatment of elderly patients, it can reduce the incidence of intraoperative hypotension or respiratory depression rate, improve the quality of recovery of elderly patients.
详细描述
Patients are fasted for at least 6 hours and water for at least 2 hours. After entering the gastroscopic room, patients took 0.1 g of dacronin hydrochloride glue in the throat for about 5 minutes, instructed the patient to be in the left recumbent position and nasal catheter oxygen (4 L / min), finger oxygen and blood pressure ; after static pushing sufentanil 0.08 μg/kg, respectively, give remimazolam or propofol for sedation; MOAA/S score ≤ 3 , start gastrointestinal endoscopy, maintain MOAA/S ≤ 4 during the operation. After the end of gastrointestinal treatment, the patient is moved to the recovery room for recovery. The evaluators also assessed the incidence of blood oxygen saturation < 90%, the incidence of respiratory rate < 8 times/min, the incidence of hypotension, the time of improved aldrete≥9, the time of discharge score ≥9 points, the postoperative cognitive function, amnesia, anxiety, dizziness, pain, nausea, and adverse events.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥60, no gender limitation;
- •Patients receiving gastroscopy or gastrointestinal endoscope;
- •ASA physical status score of I to III;
- •18 kg/m² < BMI < 30kg/m²;
- •They clearly understand and voluntarily participate in the study and sign informed consent
排除标准
- •Endoscopic diagnosis and treatment techniques with complex operation are required;
- •Patients with respiratory management difficulties;
- •Anemia or Thrombocytopenia;
- •Have a history of drug abuse and/or alcohol abuse within 2 years prior to the beginning of the screening period;
- •Patients with hypertension whose blood pressure is not satisfactorily controlled by antihypertensive medication (sital systolic blood pressure ≥160 mmHg at screening stage, and/or diastolic blood pressure ≥100 mmHg at screening stage);
- •Allergic or contraindicated to benzodiazepines, opioids, propofol, lidocaine and their components;
- •Participated in clinical trials of other drugs as a subject within the last 3 months;
- •The investigator considered the patients unfit to participate in the trial.
研究组 & 干预措施
Remimazolam group
Patients were slowly injected of 0.08 ug/kg of sufentanil. Patients received remimazolam 0.1mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure.
干预措施: Remimazolam (Drug)
Propofol group
Patients were slowly injected of 0.08 ug/kg of sufentanil for 1 min during the examination.Patients received Propofol 1.5mg/kg to maintain sufficient sedation (sufficient sedation as judged by MOAA/S ≤ 4 for 3 consecutive measurements) during endoscopy procedure.
干预措施: Propofol group (Drug)
结局指标
主要结局
Incidence of hyoxemia
时间窗: two hours
The proportion of blood oxygen saturation \< 90%.
次要结局
- Incidence of hypotension(two hours)
- Postoperative cognitive decline rate(two hours)
- Incidence of respiratory depression(two hours)
- The time of Improved Aldrete≥9(two hours)
- The time of discharge score ≥9(two hours)
- Adverse events(two hours)
- Incidence of postoperative amnesia(two hours)
- Incidence of postoperative anxiety(two hours)
- Incidence of postoperative vertigo(two hours)
- Incidence of postoperative pain(two hours)