Effect of Cyclopol on Intraoperative Electrophysiological Monitoring in Spine Surgery: A Randomized Controlled, Noninferiority Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- N75-p100 amplitude of FVEP
研究概览
简要总结
Postoperative visual function injury occurs after spinal cord, neurosurgery, ophthalmology and other operations, which directly affects the postoperative quality of life of patients. Flash visual evoked potential (FVEP) is important for evaluating visual function under general anesthesia during operation. The changes of visual function can be observed and recognized in time through the amplitude changes of FVEP, which can avoid or reduce the visual function damage during operation. Anesthesia method determines the success and variability of electrophysiological monitoring to a certain extent. The purpose of this study is to investigate the effect of total intravenous anesthesia based on cyclopol on FVEP compared with propofol.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective spinal surgery under general anesthesia;
- •Intraoperative electrophysiological monitoring is required;
- •18-65 years old;
- •Sign the informed consent.
排除标准
- •Patients with visual impairment;
- •Patients with severe liver or kidney disease;
- •Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
- •Have mental illness or unable to communicate;
- •BMI≥30kg/㎡;
- •Abuse of analgesics and drug abuse history;
- •Muscle weakness, motor dysfunction or neuromuscular junction disease before operation;
- •Preoperative somatosensory dysfunction;
- •Retain trachea catheter after operation;
- •Narcotic drugs and silicone allergy;
- •Visual evoked potential monitoring was rejected.
研究组 & 干预措施
Cyclopol group
干预措施: Cyclopol (Drug)
Propofol group
干预措施: Propofol (Drug)
结局指标
主要结局
N75-p100 amplitude of FVEP
时间窗: Intraoperative
次要结局
未报告次要终点
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital