Pharmacokinetics and Pharmacodynamics of Continuous Infusion of Remimazolam in Kidney Transplant Recipients: A Multicenter Interventional Study
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Remimazolam Plasma Concentration
研究概览
简要总结
The goal of this clinical trial is to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of remimazolam (CNS 70754) in healthy adult participants. The main questions it aims to answer are:
What are the key pharmacokinetic parameters of remimazolam, including peak concentration (Cmax), time to peak concentration (Tmax), area under the curve (AUC), and elimination half-life (T1/2)? What is the effect of remimazolam on consciousness, as measured by the MOAA/S scale and Narcotrend monitoring during anesthesia? Researchers will compare the pharmacokinetic and pharmacodynamic effects of remimazolam to see if the drug provides consistent and predictable sedation without significant adverse effects.
Participants will:
Receive continuous Infusion of Remimazolam. Have blood samples taken at various time points to measure plasma concentrations and calculate PK parameters.
Be monitored for consciousness and sedation levels using the MOAA/S scale and Narcotrend.
Undergo safety assessments, including laboratory tests, vital signs monitoring, and physical examinations throughout the study.
This study will help determine the drug's behavior in the body and its impact on sedation, providing valuable information for its future clinical use in anesthesia and other medical applications.
Last updated on December 22, 2024
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
All enrolled participants receive Remimazolam Besylate via continuous IV infusion
All enrolled participants receive a standardized Remimazolam Besylate-based anesthesia protocol for renal transplant surgery, as follows:
- Intervention Drug:
◦ Remimazolam Besylate (Trade name: Rymazol®), supplied as a lyophilized powder (25 mg/vial) reconstituted with sterile water. 2. Dosing Regimen:
- Induction: Continuous IV infusion at 6 mg/kg/h until loss of consciousness (defined as MOAA/S score ≤1).
- Maintenance: Titrated IV infusion (0.5-2 mg/kg/h) to maintain target anesthesia depth (Narcotrend Index: 27-60) until end of surgery.
- Ancillary Medications (per protocol §7.2):
- Analgesia: Sufentanil (0.4-0.5 μg/kg induction; 10 μg at peritoneum closure) + Remifentanil infusion intraoperatively.
- Muscle Relaxant: Rocuronium (0.6 mg/kg induction; 0.15 mg/kg bolus PRN).
- Immunosuppression: Methylprednisolone 750 mg + Furosemide 60 mg pre-reperfusion.
- Prohibited Agents: Sevoflurane, propofol, midazolam, dexmedetomidine, or etomidate.
- Depth Monitoring:
- Real-time Narcot
干预措施: Remimazolam Besylate (Drug)
结局指标
主要结局
Remimazolam Plasma Concentration
时间窗: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.
Blood concentration (ng/mL) of Remimazolam
Remimazolam PK Parameters
时间窗: Pre-infusion, 2/5/10/20/30/45/60/120 minutes , hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes
Percentage of AUC Extrapolated
CNS 7054 (Metabolite) PK Parameters
时间窗: During surgery: Pre-infusion, 2/5/10/20/30/45/60/120 minutes, hourly until infusion stop; Post-infusion: 0/5/15/30/60/90/120/240 minutes.
Percentage of AUC Extrapolated
Time to Loss of Consciousness (MOAA/S ≤1)
时间窗: 0 to 10 minutes after infusion start
Time from infusion start to first MOAA/S score ≤1
Sedation Depth (PD)
时间窗: Induction: every 1minutes until MOAA/S≤1; Maintenance: every 10 minutes; Recovery: every 2 minutes until 3 consecutive MOAA/S=5.
MOAA/S score (0 to 5) + Narcotrend Index (NCI 0 to 100)
Time to Full Alertness (3 consecutive MOAA/S=5)
时间窗: Time from infusion stop to sustained alertness
Time from infusion stop to sustained alertness
Narcotrend Index (NCI) Values
时间窗: Continuous monitoring during infusion + 30 min post-stop
Anesthesia depth index (0-100 scale)
次要结局
- Intraoperative Awareness Incidence(Upon PACU discharge (Day 1))
- Postoperative Urine Output(Postoperation Days 1 to 6)
- Serum Creatinine Level(Preoperation, Postoperation Days 1 to 6)
- Estimated Glomerular Filtration Rate(Preoperation, Postoperation Days 1 to 6)
- Intraoperative Bradycardia Incidence(Intra-operative period)
- Postoperative Nausea/Vomiting Incidence(PACU admission to Postoperation Day 6)
- Intraoperative Hypotension Incidence(Intra-operative period)
- Injection Pain Incidence(During induction (0 to 10 minutes))
- Postoperative Agitation Incidence(PACU stay (0 to 2 hours))
- Delayed Recovery Incidence(End of surgery to PACU discharge)
研究者
Guanghan Wu
Department of Anesthesiology and Perioperative Medicine
Qianfoshan Hospital