Study on the Quality of Recovery From General Anesthesia With Desflurane for Fundus Surgery-A Single Center, Prospective, Randomized, Double-blind, Controlled Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 220
- 主要终点
- Recovery time
研究概览
简要总结
The goal of this clinical trials to study and compare the effects of "desflurane with remifentanil anesthesia (study group)" and "sevoflurane with remifentanil anesthesia (control group)" for elective fundus surgery anesthesia. The main question it aims to answer are the characteristics of desflurane anesthesia in patients undergoing fundus surgery and to provide universal guidance for clinical application.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 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
- •ASA I-II, patients aged 18-65 years old;
- •Fundus surgery to be performed under general anesthesia ;
- •The expected duration of surgery is about 30-120 min ;
- •BMI: 18-30 kg/m2 ;
- •Those who signed the informed consent form and volunteered to participate in this trial
排除标准
- •Patients with known or suspected genetic susceptibility to malignant hyperthermia;
- •Patients with history of asthma;
- •Patients with severe heart diseases (NYHA ≥ III, severe arrhythmia, etc.) and cerebral or pulmonary diseases, liver or kidney dysfunction; or with unstable vital signs;
- •Patients with history of long-term narcotic analgesics application, including sedative and antidepressant drugs;
- •Patients with history of psychotropic drug abuse within 3 months;
- •Patients with long-term alcohol abuse;
- •People with mental disorder and unable to communicate normally;
研究组 & 干预措施
desflurane with remifentanil anesthesia
Subjects were randomly assigned to the experimental group。In this group, desflurane was inhaled at a starting concentration of 1 MAC (Minimal Alveolar Concentration), and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.
干预措施: Desflurane Inhalant Product (Drug)
sevoflurane with remifentanil anesthesia
Subjects were randomly assigned to the active comparator group。In this group, sevoflurane was inhaled at a starting concentration of 1 MAC, and remifentanil 0.1 μg/kg/min was continuously pumped intravenously.
干预措施: Desflurane Inhalant Product (Drug)
结局指标
主要结局
Recovery time
时间窗: up to 1 hour
The length of time from stopping anesthesia to patient recovery (opening eyes)
次要结局
未报告次要终点
研究者
Ting Xu
Principal Investigator
Sichuan Provincial People's Hospital