Postoperative Effects of Propofol Versus Sevoflurane Anesthesia During Elective Non-Cardiac Surgeries. A Randomized Clinical Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
研究概览
简要总结
Background: The choice of appropriate anesthetics is essential to protect brain function, decrease perioperative complications, and provide high-quality care, and better quality of life.
Objectives: To compare the efficacy and safety of propofol versus sevoflurane in patients undergoing elective, non-cardiac operations under general anesthesia.
Methods: This was a randomized (1:1), parallel, phase four clinical trial; carried out on 44 patients, who were candidates for elective, non-cardiac operations under general anesthesia at our hospital. Patients were randomly allocated into two equal groups in which anesthesia was maintained with propofol infusion in group P and sevoflurane inhalation in group S.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anesthesiologists (ASA) physical status ≤ II
- •Age from 21 years
- •Body Mass Index (BMI) 25-35 kg/m2
排除标准
- •ASA physical status > II
- •Age < 21 years
- •Patients with Montreal Objective Cognitive Assessment (MoCA-B) score < 24 points
- •Patients with significant cardiovascular, cerebrovascular, respiratory, liver, renal, endocrine, blood, or immune diseases
- •Patients with visual or auditory disease, infection, chronic inflammation, disturbance of consciousness, cognitive impairment, or dementia
- •Patients on long-term use of sedatives or steroids, alcohol or drug abuse
- •Allergy to any of the study drugs
研究组 & 干预措施
Group P (n=22)
Propofol group
干预措施: Propofol 10 MG/ML Injection (Drug)
Group S (n=22)
Sevoflurane group
干预措施: Sevoflurane Inhalation Liquid (Drug)
结局指标
主要结局
Mean and Standard deviation of Neuron Specific Enolase enzyme (µg/L) in blood serum (mean±SD)
时间窗: 24 hours after the end of operation
Before operation (T0), 1 hour after the end of operation (T1), 24 hours the end of operation (T2)
次要结局
未报告次要终点