Effects of Desflurane-propofol Balanced Anesthesia on Visual Evoked Potentials Monitoring: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- N75-p100 amplitude value
研究概览
简要总结
Intraoperative flash visual evoked potentials (FVEPs) can be used to monitor the integrity of the visual pathway in real-time during surgeries, and is to prevent the damage and deterioration of visual function caused by visual pathway damage, which is the key method of intraoperative monitoring of visual function.
Spinal surgery in the prone position may compress the eyeball and reduce the blood supply of the ophthalmic artery, which is still one of the main causes of postoperative visual impairment. Intraoperative FVEPs monitoring is easily affected by inhale anesthetics, and there is little studies on the effect of intravenous-inhalation balanced anesthesia on FVEPs monitoring. Desflurane wakes up quickly, which is conducive to the recovery of early respiratory function and orientation, and early neurological evaluation. This study aims to compare the effects of desflurane-propofol balanced anesthesia and desflurane pure inhalation anesthesia on the amplitude and latency of FVEPs during spinal surgery under the same sedation depth monitored by bispectral index (BIS) monitoring.
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 spinal cord surgery under elective general anesthesia;
- •At the same time, other electrophysiological monitoring is required;
- •18-65 years old;
- •Sign the informed consent form.
排除标准
- •Patients with visual impairment;
- •Patients with severe liver and kidney function diseases;
- •History of asthma; Uncontrolled hypertension, diabetes, severe arrhythmia or unstable angina pectoris;
- •Have mental illness or unable to communicate;
- •BMI≥30kg/m2；
- •Abuse of analgesics and drug abuse history;
- •Silicone allergy;
- •Visual evoked potential monitoring was rejected.
研究组 & 干预措施
Desflurane Inhalational group (DR group)
干预措施: Desflurane (Drug)
Desflurane propofol balanced anesthesia group (DPR group)
干预措施: Desflurane, Propofol (Drug)
结局指标
主要结局
N75-p100 amplitude value
时间窗: 60 minutes after anesthesia induction
Wave amplitude difference between N75-P100 peak and trough
次要结局
- Intraoperative vasoactive drugs dosage(The time period between the patient entering the operating room and leaving the operating room)
- N75-P100 amplitude decline rates(30minutes and 60 minutes after anesthesia induction)
- P100-N145 amplitude decline rates(30minutes and 60 minutes after anesthesia induction)
- Success rate of FVEP monitoring(30minutes and 60 minutes after anesthesia induction)
- P100 latency prolongation rate(30minutes and 60 minutes after anesthesia induction)
- FVEPs stacking satisfaction(Intraoperative)
- Respiratory recovery time(Within 60 minutes after surgery)
- Eye-opening time(Within 60 minutes after surgery)
- Extubation time(Within 60 minutes after surgery)
- Postextubation agitation score(Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.)
- Intraoperative anesthetic drugs dosage(The time period between the patient entering the operating room and leaving the operating room)
- Ramsay Sedation Score(Immediately after extubation, 15 minutes after extubation, 30 minutes after extubation, 1 hour after extubation.)
研究者
Ruquan Han
Professor
Beijing Tiantan Hospital