Comparison of Remimazolam and Propofol Combination vs. Propofol in Intraoperative Neurophysiologic Monitoring: A Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 56
- 主要终点
- Incidence of intraoperative hypotension
研究概览
简要总结
This study aims to compare total intravenous anesthetic agents: combined remimazolam and propofol vs. propofol monotherapy. The comparison parameters are intraoperative hypotension, patient's involuntary movement, neurophysiological monitoring quality, onset time, recovery time, and postoperative rescue anti-emetics requirements.
详细描述
This study hypothesizes that the combination regimen of remimazolam and propofol as total intravenous anesthesia in neurosurgical procedures requiring neurophysiological monitoring can reduce the incidence of hypotension compared to propofol monotherapy while providing comparable levels of neurophysiological monitoring and surgical conditions. With this hypothesis, the study aims to compare the frequency, severity, and duration of hypotension, frequency of patient movement, and appropriateness of neurophysiological monitoring between the combination therapy of remimazolam and propofol and propofol monotherapy in total intravenous anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 and above with planned neurosurgical procedures requiring neurophysiological monitoring, classified as American Society of Anesthesiologists (ASA) physical status classification 1, 2, or 3 in the United States.
排除标准
- •Patients who refuse to participate in the study.
- •Patients who are pregnant or lactating.
- •Patients with hypersensitivity to the investigational drugs or to soy, peanuts, or Dextran
- •Patients with acute narrow-angle glaucoma.
- •Patients with alcohol or drug dependence.
- •Patients with hepatic impairment classified as Child-Pugh class C.
- •Patients with lactose intolerance.
- •Patients requiring emergency surgery.
研究组 & 干预措施
Combination group
Combination regimen (remimazolam plus propofol)
干预措施: Remimazolam besylate + propofol MCT (Drug)
Propofol group
Propofol monotherapy
干预措施: Propofol MCT (Drug)
结局指标
主要结局
Incidence of intraoperative hypotension
时间窗: operation day - postoperative 1 day
mean arterial pressure \< 65mmHg
次要结局
- scores of neurophysiologic monitoring quality(operation day - postoperative 1 day)
- Amount and number of inotropic agents(operation day - postoperative 1 day)
- Incidence of participants' intraoperative involuntary movement(operation day - postoperative 1 day)
- onset time of study drugs(operation day - postoperative 1 day)
- The administration number of rescue anti-emetic agents(operation day - postoperative 3 day)
- Time-weighted average of intraoperative hypotension(operation day - postoperative 1 day)
- recovery time of study drugs (remimazolam+propofol or propofol)(operation day - postoperative 1 day)
研究者
Jiwon Han
Assistant professor
Chung-Ang University Gwangmyeong Hospital