Comparison of Efficacy and Safety Between Eleveld PK/PD Model-based Dosing and Standard Dosing During General Anesthesia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Eye-Opening Time, EOT
研究概览
简要总结
The goal of this randomized, controlled clinical trial is to evaluate the efficacy, safety, and recovery profile of an individualized, Eleveld pharmacokinetic/pharmacodynamic model-guided dosing strategy for remimazolam in adult patients undergoing elective non-cardiac surgery under general anesthesia.
The main questions it aims to answer are:
Does Eleveld model-guided customized dosing significantly reduce the eye-opening time at the end of surgery compared to standard weight-based dosing?
Can the Eleveld model-guided approach prevent relative drug accumulation and delayed emergence while maintaining an adequate depth of anesthesia and comparable hemodynamic stability?
Researchers will compare the Experimental Group (Eleveld model-guided dosing) to the Control Group (Standard weight-based label dosing) to see if preemptive dose optimization based on individual patient covariates effectively reduces the total drug consumption, frequency of rescue flumazenil administration, and emergence time.
Participants will:
- Be randomly assigned to receive remimazolam for the induction and maintenance of general anesthesia according to either the Eleveld model-guided customized regimen or the standard weight-based regimen.
- Have their depth of anesthesia continuously monitored using a Bispectral Index (BIS) sensor.
- Be assessed for the primary outcome (time to eye-opening upon verbal command after discontinuation of anesthetics) and secondary outcomes, including total drug consumption, hemodynamic stability, and postoperative complications (e.g., re-sedation, delirium, PONV).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 19 to 79 years undergoing elective non-cardiac surgery expected to last 60 minutes or longer under general anesthesia with endotracheal intubation
排除标准
- •Emergency surgery
- •Surgery requiring evoked potential (EP) monitoring
- •Chronic benzodiazepine users
- •Body Mass Index (BMI) ≥ 35 kg/㎡
- •Chronic kidney disease
- •Hepatic dysfunction or chronic liver disease
- •Contraindication or history of hypersensitivity to remimazolam
- •American Society of Anesthesiologists (ASA) physical status ≥ IV
- •Pregnant women
- •Contraindication or history of hypersensitivity to flumazenil
研究组 & 干预措施
Eleveld model-guided dosing
Dosage calculated with Eleveld PK/PD model
干预措施: Eleveld model-guided dosing (Drug)
Standard weight-based label dosing
Loading with 9 mg/kg/h until loss of consciousness, then maintenance with 1-2 mg/kg/h
干预措施: Standard weight-based label dosing (Drug)
结局指标
主要结局
Eye-Opening Time, EOT
时间窗: Time from the discontinuation of remimazolam to eye-opening upon verbal command (min), up to 1h
次要结局
- Total dose of intraoperative remimazolam (mg)(Perioperative/Periprocedural)
- Total dose of intraoperative remifentanil (㎍)(Perioperative/Periprocedural)
- Incidence of intraoperative hypotension (mean blood pressure < 65 mmHg)(Perioperative/Periprocedural)
- Incidence of intraoperative hypertension (SBP > 140 mmHg)(Perioperative/Periprocedural)
- Time to loss of consciousness (LOC)(Time from the start of remimazolam administration to loss of consciousness (min), up to 1h)
- Intraoperative Bispectral Index (BIS) values(Perioperative/Periprocedural)
- Incidence of intraoperative bradycardia (heart rate < 45 bpm)(Perioperative/Periprocedural)
- Incidence of intraoperative tachycardia (heart rate > 110)(Perioperative/Periprocedural)
- Total dose(s) of intraoperative vasopressor(s)(Perioperative/Periprocedural)
- Extubation time (min)(Time from the discontinuation of remimazolam to the removal of the endotracheal tube, up to 1h)
- Incidence of flumazenil administration(From discontinuation of remimazolam to patient discharge from the operating room, up to 1h)
- Incidence of rescue sevoflurane use(Perioperative/Periprocedural)
- Incidence of oxygen supplementation in the Post-Anesthesia Care Unit (PACU)(Perioperative/Periprocedural, on the day of surgery)
- Incidence of postoperative delirium(Perioperative/Periprocedural, up to 1 week)
- Incidence of postoperative nausea and vomiting (PONV)(Perioperative/Periprocedural, up to 1 week)
- Length of stay in the PACU (min)(Perioperative/Periprocedural, on the day of surgery)
- Incidence of re-sedation(Perioperative/Periprocedural, on the day of surgery)
- Incidence of intraoperative awareness(Perioperative/Periprocedural)
研究者
Hansol Kim, MD
Clinical Assistant Professor
Seoul National University Hospital