Remimazolam Versus Propofol for General Anesthesia Induction in Patients on Renin-angiotensin System Blockers Undergoing Robot-assisted Laparoscopic Prostatectomy: A Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 试验地点
- 1
- 主要终点
- Hypotension occurrence (unit: number of patients)
研究概览
简要总结
The investigators conduct a random assignment into either the remimazolam group or the propofol group. Depending on the group assignment, either remimazolam (0.2 mg/kg) or propofol (1.0 mg/kg) is administered. If necessary, additional doses of remimazolam (0.1 mg/kg) or propofol (0.5 mg/kg) are given. The standard anesthesia procedure of our institution is followed, and blood pressure data recorded during the surgery is analyzed (mean arterial pressure <65mmHg is defined as hypotension).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients who undergo robot-assisted laparoscopic prostatectomy and who have taken renin-angiotensin system blockers for more than 3 months.
排除标准
- •emergency surgery
- •If the subject includes those who cannot read the consent form (e.g. illiterate, foreigners, etc.)
- •cognitive dysfunction
- •Atrial fibrillation, moderate to severe valvular disease, ejection fraction of 35% or less
- •Patients who did not take renin-angiotensin system blockers on the day of surgery
研究组 & 干预措施
Group remimazolam
During anesthesia induction, the remimazolam group (group R) receives remimazolam (0.2 mg/kg). If necessary, an additional dose of remimazolam (0.1 mg/kg) is administered.
干预措施: remimazolam (Drug)
Group propofol
During anesthesia induction, the propofol group (group P) receives propofol (1.0 mg/kg). If necessary, an additional dose of propofol (0.5 mg/kg) is administered.
干预措施: Propofol (Drug)
结局指标
主要结局
Hypotension occurrence (unit: number of patients)
时间窗: during the total anesthesia duration
"MAP\<65mmHg for 1 min
Vasopressor dose (unit: mcg for norepinephrine)
时间窗: during the total anesthesia duration
total dose of norepinephrine administered
Amount of hypotension (unit: mmHg)
时间窗: during the total anesthesia duration
time-weighted average MAP \<65mmHg =\> depth of hypotension (mmHg) below a MAP of 65 mmHg \* time (min) below a MAP of 65 mmHg)/ total duration of surgery (min)
Vasopressor dose (unit for vasopressin)
时间窗: during the total anesthesia duration
total dose of vasopressin administered
次要结局
未报告次要终点