The Impact of Administration of Flumazenil on the Emergence Delirium in Patients Anesthetized With Remimazolam: a Prospective Randomized Single-blind Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- Incidence of emergence delirium
研究概览
简要总结
Flumazenil rapidly antagonizes benzodiazepines (BZDs); it may induce agitation, seizure, or delirium, especially when applied to patients who have taken BZDs for a long time. On the contrary, it may help patients regain consciousness in a stable and calm state by appropriately reversing the central nervous system depressant effects of BZDs. In this study, we aim to investigate the impact of flumazenil on the emergence delirium in patients anesthetized with remimazolam, the short-acting BZD drug.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Adult patients aged 19 years or older undergoing surgery under general anesthesia
排除标准
- •Peripheral nerve block or Neuraxial block
- •Uncontrolled hypertension (HTN) (systolic blood pressure (SBP) ≥180 mmHg)
- •Uncontrolled diabetes mellitus (DM) (HbA1c ≥9.0%)
- •Hepatic dysfunction (Total bilirubin ≥3.0 mg/mL or Liver enzyme ≥Upper normal limit x 2.5)
- •Renal dysfunction (Estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m2 or Dialysis)
- •Moderate or severe chronic obstructive pulmonary disease or Respiratory failure
- •Emergency
- •Hepatectomy or Liver transplantation
- •Intraoperative cardiopulmonary bypass (CPB) or extracorporeal membrane oxygenation (ECMO) use
- •Head trauma, Increased intracranial pressure, Craniotomy
- •Chronic use of benzodiazepines (BZDs)
- •Anxiety, Alcohol/Drug dependence, Addiction to tricyclic antidepressants (TCAs)
- •Allergic reaction to BZDs, flumazenil, or other drugs used in general anesthesia
- •Severe allergy or Anaphylaxis history
- •Lactose-related genetic disorders
- •Myasthenia gravis or Myasthenia gravis syndrome
- •Myocardial infarction or Cerebrovascular events within 6 months
- •Symptomatic coronary artery disease
- •Organic brain disease
- •Cognitive impairment (Inability to understand informed consent)
研究组 & 干预措施
Flumazenil group
After discontinuation of remimazolam administration, flumazenil is administered to help the patient recover consciousness.
干预措施: Flumazenil (Drug)
结局指标
主要结局
Incidence of emergence delirium
时间窗: From emergence to postanesthesia care unit (PACU) discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery]
Richmond Agitation \& Sedation Scale (RASS) ≥1 is considered emergence delirium.
次要结局
- Duration of POD(From PACU to postoperative day 5)
- Incidence of resedation(From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery)
- Time to eye-opening(After remimazolam cessation to eye-opening [within 30 min after remimazolam cessation])
- Postoperative nausea/vomiting (PONV)(From immediately after extubation to PACU discharge [within 2 hours after surgery])
- Incidence of postoperative delirium (POD)(From PACU to postoperative day 5(until the discharge date if discharged before 5 days after surgery) [2 times a day in the morning/afternoon])
- Severity of POD(From PACU to postoperative day 5)
- Level of consciousness(From emergence to PACU discharge (Immediately after extubation, 15 min after PACU admission, PACU discharge) [within 2 hrs after surgery)
- Postoperative pain(From PACU admission to postoperative day 5)
- Time to extubation(After remimazolam cessation to extubation [within 30 min after remimazolam cessation])
- Preoperative anxiety(1 day before surgery)
- Postoperative hospital length of stay(From the day of surgery to the day of hospital discharge [within 1 month])
研究者
Byung Gun Lim
Professor
Korea University Guro Hospital