Application of Flumazenil to Antagonize Remimazolam and Evaluation of Remimazolam Plasma Concentration in Kidney Transplant Patients: A Randomized Controlled Trial
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Plasma Concentration of Remimazolam
研究概览
简要总结
To investigate the effect of different doses of flumazenil antagonism on remimazolam plasma concentration in patients undergoing renal transplantation under general anesthesia.
详细描述
During the surgery, other anesthetics, intraoperative monitoring, fluid management, and postoperative pain management were implemented according to a unified standard.
- Intraoperative Monitoring All study participants underwent the following routine intraoperative monitoring: blood pressure, electrocardiogram, pulse oximetry, end-tidal CO2 pressure, body temperature, and depth of anesthesia monitoring. Additional monitoring such as central venous pressure, invasive continuous arterial blood pressure, and cardiac output was selected based on clinical needs and the attending anesthesiologist's judgment.
- Anesthetic Regimen
All study participants underwent general anesthesia with endotracheal intubation and received total intravenous anesthesia with remimazolam. For anesthesia induction, it was recommended to administer remimazolam at a rate of 6-12 mg/kg/h until loss of consciousness; for maintenance, it was recommended to administer at a rate of 0.5-2.0 mg/kg/h. At the end of anesthesia:
C Group: Immediately after surgery, an equal volume of saline (equal to the volume of 0.5 mg flumazenil) was administered, followed by an equal volume of saline (equal to the volume of 0.3 mg flumazenil) 25 minutes later.
R1 Group: Immediately after surgery, 0.5 mg flumazenil was administered, followed by an equal volume of saline (equal to the volume of 0.3 mg flumazenil) 25 minutes later.
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
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Age ≥ 18 years and < 65 years
- •Patients undergoing elective kidney transplant surgery
- •Signed the informed consent for the clinical study
排除标准
- •Liver decompensation (Child B/C)
- •History of liver transplant
- •Previous allergies or other serious adverse reactions to narcotic drugs
- •Intraoperative depth monitoring of anesthesia is not expected
- •Preoperative ASA rating of 5
- •Received general anesthesia in the 30 days prior to surgery or plan to receive it again within 30 days
- •Plan to extend airway protection or mechanical ventilation support time after surgery
- •Previous participation in this study
研究组 & 干预措施
"Flumazenil group 1（F1 group）"+"Flumazenil group 2（F2 group）"
"Flumazenil group 1（F1）":Immediately after surgery, 0.5 mg flumazenil was administered, followed by an equal volume of saline (equal to the volume of 0.3 mg flumazenil) 25 minutes later.
"Flumazenil group 2（F2）":Immediately after surgery, 0.5 mg flumazenil was administered, followed by 0.3 mg flumazenil 25 minutes later.
干预措施: Flumazenil Injection（F1 group） (Drug)
"Flumazenil group 1（F1 group）"+"Flumazenil group 2（F2 group）"
"Flumazenil group 1（F1）":Immediately after surgery, 0.5 mg flumazenil was administered, followed by an equal volume of saline (equal to the volume of 0.3 mg flumazenil) 25 minutes later.
"Flumazenil group 2（F2）":Immediately after surgery, 0.5 mg flumazenil was administered, followed by 0.3 mg flumazenil 25 minutes later.
干预措施: Flumazenil Injection（F2 group） (Drug)
Control Group (C group)
Immediately after surgery, an equal volume of saline (equal to the volume of 0.5 mg flumazenil) was administered, followed by an equal volume of saline (equal to the volume of 0.3 mg flumazenil) 25 minutes later.
干预措施: Saline（C group） (Drug)
结局指标
主要结局
Plasma Concentration of Remimazolam
时间窗: T3 (50 minutes after the end of surgery)
3ml arterial blood was drawn to determine the blood concentration of remimazolam
次要结局
- Oxygen Saturation (SpO2)(T3（50 minutes after the end of surgery))
- Record eye opening time and extubation time(after surgery,an average of 30 minutes)
- Blood Pressure (BP)(T3（50 minutes after the end of surgery))
- remimazolam usage(immediately at the end of surgery)
- The amount of analgesic drugs used during operation(3 days after surgery)
- Bispectral Index (BIS)(T3 (50 minutes after the end of surgery))
- Duration of Post-Anesthesia Care Unit (PACU) Stay(Before Leaving PACU Post-Surgery)
- Heart Rate (HR)(T3（50 minutes after the end of surgery))
- Mean Arterial Pressure (MAP)(T3（50 minutes after the end of surgery))
- Occurrence of nausea(3 days after surgery)
- Occurrence of vomiting(3 days after surgery)
- Number of Participants with Postoperative Pulmonary Atelectasis, Cardiovascular and Cerebrovascular Adverse Events(30 days after surgery)
- All-cause death within 30 days after surgery(30 days after surgery)
- Total hospital stay for survivors 30 days after surgery(30 days after surgery)
- Unplanned second hospital admission within 30 days after surgery(30 days after surgery)
- Mini-Mental State Examination （MMSE )scores were obtained before, 24h and 72h after surgery(Entering the Operating Room, Before Anesthesia)
- Mini-Mental State Examination （MMSE ）scores(72 h after the end of surgery)
研究者
Jianbo Wu
Chief Physician
Qianfoshan Hospital