Effect of Remimazolam Induction on the Recovery Quality After Day Surgery in Elderly Patients: a Comparison Study With Etomidate
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 118
- 试验地点
- 3
- 主要终点
- The quality of recovery 15
研究概览
简要总结
The goal of this clinical trial is to compare remimazolam and etomidate in inducing quality of recovery after day surgery for laryngeal mask general anesthesia in elderly patients. The main question it aims to answer is:
• The quality of postoperative recovery induced by remimazolam for laryngeal mask general anesthesia in elderly patients undergoing day surgery is not inferior to that induced by etomidate Participants will be given remimazolam to induce anesthesia。 Researchers will compare etomidate to see if the quality of postoperative recovery.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •undergoing day surgery under laryngeal mask anesthesia
- •American society of anesthesiologists (ASA) grade 1-3
- •BMI<30kg/m2
排除标准
- •have benzodiazepines drugs in the latest month cognitive dysfunction
- •Cognitive dysfunction and neuropsychiatric disorders
- •It was estimated as a difficult airway
- •There was a history of adrenal insufficiency, porphyria, or chronic corticosteroid therapy
- •There is a contraindication or allergy to benzodiazepines, opioids, etomidate and its components
研究组 & 干预措施
remimazolam
remimazolam induction
干预措施: Remimazolam besylate (Drug)
etomidate
etomidate induction
干预措施: etomidate (Drug)
结局指标
主要结局
The quality of recovery 15
时间窗: postoperative day 1
The main goal of this study was to assess the QoR using the QoR-15 questionnaire, which is a global measure of recovery after surgery that evaluates five dimensions of recovery: physical comfort (5 items), physical independence (2 items), emotional state (4 items), psychological support (2 items), and pain (2 items). Each item is rated on an 11- point scale based on its frequency on the questionnaire (greater score at greater frequency for positive items and less frequency for negative items). The total score ranged from 0 (poorest recovery quality) to 150 (best recovery quality).
次要结局
- The time of loss of consciousness(within 3 minutes after the end of the intravenous anesthetic)
- pulse oxygen saturation(From 5 minutes before anesthesia induction to the time point surgery start)
- Adverse events(During stay of post anesthesia care unit (up to 30minutes）)
- the mean blood pressure，the systolic blood pressure ，the diastolic pressure(From 5 minutes before anesthesia induction to the time point surgery start)
- heart rate(From 5 minutes before anesthesia induction to the time point surgery start)