Comparison of Anesthetic Induction Time and Change of Bispectral Index Between Intravenous Bolus Administration and Continuous Infusion of Remimazolam for Anesthetic Induction: a Prospective Randomized Single-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- MOAA/SS (sedation level)
研究概览
简要总结
Bolus injection and continuous infusion are two widely used methods for intravenous administration of drugs. Bolus injection possibly leads to a rather high drug plasma concentration temporarily, however, it can induce a rapid onset of drug effects and attain a desired clinical state fast. On the contrary, continuous infusion is able to avoid excessive drug levels in plasma, but it takes longer to achieve the proper effect.
In this study, the investigators hypothesize that the bolus injection of remimazolam can reduce anesthesia induction time when compared to the continuous infusion of remimazolam, and also maintain hemodynamic stability. (The researchers will investigate the effect of the bolus injection of remimazolam during anesthesia induction in terms of its safety and efficacy when compared with the continuous infusion.)
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
- Single (Participant)
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
- •Adults 19 years of age or older undergoing surgery under general anesthesia
- •ASA I-III
排除标准
- •Intraoperative regional blocks (e.g. spinal anesthesia, epidural anesthesia, peripheral nerve block)
- •Liver resection or liver transplantation
- •Cardiopulmonary bypass
- •Uncontrolled HTN (SBP ≧180 mmHg, or ≧160 in patients taking antihypertensive drugs)
- •Uncontrolled DM (HbA1c antihypertensive drugs ≧9.0%)
- •Total bilirubin ≧3.0 mg/ml or AST or ALS ≧2.5 times the upper limit of normal
- •Serum creatinine ≧2.0 mg/ml or ESRD on dialysis
- •COPD in need of treatment
- •Patients who are expected to have difficulty in tracheal extubation immediately after surgery for postoperative lung management
- •Resistance to benzodiazepines
- •Hypersensitivity to benzodiazepines, remifentanil, fentanyl citrate, rocuronium, sugammadex, flumazenil, or other anesthetic drugs
- •Myasthenia gravis or myasthenic syndrome
- •Myocardial infarction, transient ischemic attack, stroke, newly diagnosed coronary artery disease, percutaneous coronary intervention, or coronary artery bypass graft within 6 months
- •Implantation of rate-responsive cardiac pacemaker with bioelectrical impedance sensor
- •Organic brain disorder, or other neurologic diseases that cannot adequately measure EEG (BIS)
- •Severe allergic diseases
- •Cognitive impairment that makes it impossible to understand the instructions and informed consent of this study
研究组 & 干预措施
Infusion group
Participants in this group are administered remimazolam via the continuous infusion method during anesthesia induction.
干预措施: Infusion of remimazolam (Drug)
Bolus group
Participants in this group are administered remimazolam via the bolus injection method during anesthesia induction.
干预措施: Bolus injection of remimazolam (Drug)
结局指标
主要结局
MOAA/SS (sedation level)
时间窗: From initiation of remimazolam to LOC (up to 5 minutes)
The investigators will measure MOAA/SS from the start of remimazolam administration to loss of consciousness (LOC), and compare it between the two groups.
次要结局
- Time from initiation of drug administration to bispectral index(BIS) <60(From initiation of remimazolam to BIS <60 (up to 10 minutes))
- Hemodynamic stability (i.e. blood pressure, heart rate)(From initiation of remimazolam to 15 minutes after surgical incision)
- BIS(From initiation of remimazolam to 15 minutes after surgical incision)
研究者
Byung Gun Lim
Professor
Korea University Guro Hospital