Comparison of Remimazolam-based Monitored Anesthesia Care With Inhalation General Anesthesia Under the Guidance of an ANI Monitor During TURB: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- anesthesia time excluding operation time
研究概览
简要总结
In patients undergoing transurethral resection of bladder, the effect of remimazolam-based monitored anesthesia care (MAC) and inhalational general anesthesia will be compared under guidance by analgesia nociception index (ANI) monitoring. Anesthesia time, operation time, anesthesia time excluding operation time and total dose of opioid will be compared.
详细描述
In remimazolam-based MAC group, anesthesia will be induced with remimazolam and spontaneous breathing will be maintained. The dose of remimazolam and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).
In inhalation general anesthesia group, anesthesia will be induced with propofol and rocuronium and maintained with sevoflurane and remifentanil. Mechanical ventilation will be maintained by inserting laryngeal mask airway (LMA) or endotracheal tube. The doses of sevoflurane and remifentanil will be adjusted according to the patient state index (PSI) and the analgesia nociception index(ANI).
Surgery cost, anesthesia cost, patient and surgeon's satisfaction score, pain score, PONV score and the incidence of hypotension and hypoxemia will be compared.
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
- None
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients undergoing transurethral bladder resection
排除标准
- •ASA class 4
- •emergency surgery
- •history of hypersensitivity to sevoflurane, propofol and remimazolam
- •galactose intolerance
- •patient refusal
- •patients in whom muscular relaxation are needed.
研究组 & 干预措施
remimazolam based MAC group
remimazolam based monitored anesthesia care
干预措施: remimazolam based MAC (Drug)
inhalation general anesthesia group
general anesthesia with sevoflurane
干预措施: general anesthesia with sevoflurane (Drug)
结局指标
主要结局
anesthesia time excluding operation time
时间窗: 0-1 hour after the end of surgery (Time point at which patient exit the operating room)
anesthesia time excluding operation time
次要结局
- incidence of hypotension(At the end of surgery)
- incidence of hypoxemia(At the end of surgery)
- surgeon's satisfaction score(At the end of surgery)
- patient's satisfaction score(0-2 hour after surgery (Time points at patient discharge from recovery room))
- surgery cost and anesthesia cost(1 month after surgery)
- PONV score(0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery)
- pain score(0-2 hour after surgery (Time points at patient discharge from recovery room), and 6 hour after surgery)