Comparison of Intraoperative Remifentanil Requirements During Remimazolam Versus Propofol Total Intravenous Anesthesia With Analgesia Nociception Index-guided Remifentanil Administration: a Randomized Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Intraoperative remifentanil consumption (mcg/kg/min)
研究概览
简要总结
The investigators hypothesized that intraoperative opioid consumption would be different between remimazolam and propofol if the ANI-guided remifentanil continuous infusion rate was adjusted when the depth of anesthesia was maintained at similar depths with remimazolam or propofol under total intravenous anesthesia. The purpose of this study is to compare the intraoperative remifentanil requirement in patients undergoing total knee arthroplasty when the intraoperative remifentanil dose adjustment was performed under the ANI guidance while maintaining a similar depth of anesthesia with remimazolam or propofol.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 19~80 years of age who are expected to elective total knee arthroplasty under general anesthesia
排除标准
- •Second total knee arthroplasty under a prior plan of staged total knee arthroplasty, both
- •Previous hepatectomy or liver transplant
- •Estimated glomerular filtration rate < 30 mL/min/1.73m2
- •Patients with moderate or more hepatic impairment (AST/ALT is more than 2.5 times the upper limit of normal)
- •Uncontrolled hypertension (systolic blood pressure > 160mmHg)
- •Acute narrow angle glaucoma
- •Myasthesia gravis
- •Known allergy to the drugs included in the study
- •Cardiac arrhthmia (non-sinus rhythm)
- •Taking drugs that affect the autonomic nervous system of diabetes
- •Psychiatric or neurologic disease (major depression disorder, dementia or cerebral infarction)
- •History of drug or alcohol abuse
研究组 & 干预措施
Remimazolam group
Total intravenous anesthesia with remimazolam and remifentanil
干预措施: remimazolam group (Drug)
Propofol group
Total intravenous anesthesia with propofol and remifentanil
干预措施: propofol group (Drug)
结局指标
主要结局
Intraoperative remifentanil consumption (mcg/kg/min)
时间窗: Day 0, intraoperative
At the start of anesthesia induction, intravenous remifentanil infusion is started and the intraoperative remifentanil infusion rate is adjusted based on the ANI 50 during surgery. The total dose of remifentanil infused intraoperatively is recorded.
次要结局
- Numeric rating scale pain score at rest(up to 24 hours after the surgery)
- Postoperative opioid consumption(up to 24 hours after the surgery)
研究者
Do-Hyeong Kim
Profeesor
Gangnam Severance Hospital