The Comparison of Hemodynamic Effects Between Remimazolam-remifentanil and Propofol-remifentanil in Patients Undergoing Laparoscopic Cholecystectomy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Percent of patients with hypotension event
研究概览
简要总结
This study is conducted to determine whether the occurrence of hypotension is reduced by the combined use of remimazolam and remifentanil compared to the conventional combination use of propofol and remifentanil. Patients enrolled in the study are infused continuously with either propofol or remimazolam from the start of anesthesia to the end of surgery.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients 19 years of age or older
- •the American Society of Anesthesiologists classification 1-3
- •patients undergoing laparoscopic cholecystectomy at Severance Hospital
排除标准
- •Emergency surgery,
- •patients with heart disease or arrhythmias,
- •patients undergoing concurrent surgery other than laparoscopic cholecystectomy,
- •obesity (BMI>30),
- •patients who were admitted on the surgery day,
- •foreigners,
研究组 & 干预措施
propofol group
During induction, the propofol group starts the effect site concentration at 4.0 ng/ml with TCI and adjusts it to around 3.0 ~ 4.0 ng/ml after intubation to maintain an appropriate EEG-based depth of anesthesia.
干预措施: propofol group (Drug)
remimazolam group
Arm Description: In the remimazolam group, start remimazolam at 6 mg/kg/hr and adjust it to 1 mg/kg/hr after loss of consciousness to maintain an appropriate EEG-based depth of anesthesia.
干预措施: remimazolam group (Drug)
结局指标
主要结局
Percent of patients with hypotension event
时间窗: from start of drugs to end of anesthesia on the surgery 1 day
次要结局
- difference of QOR-40 score(Baseline (preoperative period) and Postoperative day 1)
- time-weighted average of hypotension(from start of drugs to end of anesthesia on the surgery 1 day)
- dose of Norepinephrine or nicardipine(from start of drugs to end of anesthesia on the surgery 1 day)
- Heart rate variability(from start of drugs to end of anesthesia on the surgery 1 day)
- Sedline(Psi)(from start of drugs to end of anesthesia on the surgery 1 day)