Effect of Remazolam on Anesthesia Recovery in Patients Undergoing 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
- 93
- 主要终点
- time for recovery
研究概览
简要总结
to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery
详细描述
to investigate the effect of remazolam benzenesulfonate in patients with ocular fundus surgery, so as to guide clinical anesthesiologists to choose more appropriate anesthetic drugs in fundus surgery。There are three groups.In Group H, ciprofol + Remifentanil was used for maintenance of anesthesia, in Group R, remifentanil + Remifentanil was used for maintenance of anesthesia, in Group RF, remifentanil + Remifentanil was used for maintenance of anesthesia, at the end of the operation, flumazenil was used to counteract the residual anesthetic effect.The quality of postoperative recovery was compared
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
Remazolam combined with Remifentanil anesthesia
0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously.
干预措施: Remazolam (Drug)
Remazolam combined with Remifentanil anesthesia
0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously.
干预措施: Remifentanil (Drug)
ciprofol combined with Remifentanil anesthesia
0.4mg/kg ciprpfol and 2ug/kg Remifentanil for induction of anesthesia,remifentanil 0.1 μg/kg/min and 0.4-2.4mg/kg/h ciprpfol were continuously pumped intravenously.
干预措施: ciprofol (Drug)
ciprofol combined with Remifentanil anesthesia
0.4mg/kg ciprpfol and 2ug/kg Remifentanil for induction of anesthesia,remifentanil 0.1 μg/kg/min and 0.4-2.4mg/kg/h ciprpfol were continuously pumped intravenously.
干预措施: Remifentanil (Drug)
The flumazenil was injected at the end of the surgery
0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously. The 0.5mg flumazenil was injected at the end of the surgery
干预措施: Remazolam (Drug)
The flumazenil was injected at the end of the surgery
0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously. The 0.5mg flumazenil was injected at the end of the surgery
干预措施: Flumazenil (Drug)
The flumazenil was injected at the end of the surgery
0.2mg/kg Remazolam and 2ug/kg Remifentanil for induction of anesthesia, remifentanil 0.1 μg/kg/min and 0.2mg/kg Remazolam were continuously pumped intravenously. The 0.5mg flumazenil was injected at the end of the surgery
干预措施: Remifentanil (Drug)
结局指标
主要结局
time for recovery
时间窗: 3 second to 30minutes
The time from stopping the anesthetic to waking up
次要结局
未报告次要终点
研究者
Ting Xu
Principal Investigator
Sichuan Provincial People's Hospital