Efficacy and Safety of Different Doses of Midazolam for 24-Hour Continuous Sedation in Pre-Eclamptic Women Undergoing Cesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Maternal anxiety reduction using Visual Analog Anxiety Rating Scale (VAS-A)
研究概览
简要总结
This study will compare four different doses of midazolam (0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg) administered intravenously to women with pre-eclampsia undergoing cesarean section. The study aims to evaluate how these different doses affect:
The mother's vital signs (oxygen levels, blood pressure, heart rate) The mother's anxiety levels The baby's condition after birth Any potential side effects Participants will be randomly assigned to one of the four dose groups. Medical staff will monitor both mother and baby for 24 hours after the medication is given.
详细描述
This study aimed to investigate the efficacy and safety of different doses of midazolam for 24-hour continuous sedation in pre-eclamptic women undergoing cesarean section. A total of 124 pre-eclamptic women admitted from April 2021 to April 2023, scheduled for cesarean section at our hospital, were randomly assigned to Group A, Group B, Group C, and Group D, with 31 women in each group. Midazolam was administered intravenously at doses of 0 mg/kg, 0.01 mg/kg, 0.02 mg/kg, and 0.03 mg/kg, respectively. We compared the oxygen saturation (SPO2), mean arterial pressure (MAP), and heart rate (HR) levels before and 30 minutes after drug administration in all four groups. Visual anxiety scores, fetal Kreb's scores, and sedation efficacy indicators (fentanyl dosage, onset time of sedation, mechanical ventilation time) were assessed in the women at 24 hours before and after the surgery. Adverse reactions were also recorded.
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
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women diagnosed with pre-eclampsia [6] requiring emergency or planned cesarean section
- •Age 18-40 years
- •No history of midazolam or related drug allergies
- •Able to comply with study protocol (no communication barriers)
- •No history of mental illness or substance abuse
- •Provided informed consent (patient or legal representative)
排除标准
- •Concurrent use of drugs interacting with midazolam
- •Severe organ dysfunction (heart, liver, or kidneys)
- •Participation in other clinical trials potentially affecting results
- •Coagulation disorders or hematological conditions
- •Inability to adhere to study protocol
- •Severe intraoperative complications (e.g., hemorrhage) compromising data reliability
- •Additional sedative/analgesic use within 24 hours post-cesarean
研究组 & 干预措施
0 mg/kg Midazolam (Control Group)
- Received intravenous saline placebo (volume-matched to active doses)
- Standard epidural anesthesia with 1.6% lidocaine (15-18 mL to T6 level)
- Hemodynamic monitoring per protocol
干预措施: 0 mg/kg Midazolam (Control Group) (Drug)
0.01 mg/kg Midazolam Group
- Intravenous midazolam at 0.01 mg/kg (Jiangsu Enhua Pharmaceutical Co., Ltd.)
- Standard epidural anesthesia as in Arm 1
- Continuous sedation monitoring for 24 hours post-dose
干预措施: 0.01 mg/kg Midazolam Group (Drug)
0.02 mg/kg Midazolam Group
- Intravenous midazolam at 0.02 mg/kg
- Identical anesthesia and monitoring protocols as other arms
- Primary focus: Dose-response evaluation for sedation efficacy
干预措施: 0.02 mg/kg Midazolam Group (Drug)
0.03 mg/kg Midazolam Group
- Intravenous midazolam at 0.03 mg/kg (highest tested dose)
- Enhanced monitoring for hemodynamic effects (MAP, HR, SpO₂)
- Primary focus: Optimal dose determination balancing efficacy/safety
干预措施: 0.03 mg/kg Midazolam Group (Drug)
结局指标
主要结局
Maternal anxiety reduction using Visual Analog Anxiety Rating Scale (VAS-A)
时间窗: 24 hours after cesarean section.
Comparison of anxiety scores using the Visual Analog Anxiety Rating Scale (VAS-A; range 0-10 cm, where 0 = "no anxiety" and 10 = "worst possible anxiety") at 24 hours post-cesarean section among groups receiving different midazolam doses (0, 0.01, 0.02, or 0.03 mg/kg). Higher scores indicate worse anxiety.
次要结局
- Fentanyl consumption during sedation(Intraoperative period through 24 hours post-surgery)
- Sedation onset time(0-60 minutes post-dose)
- Mechanical ventilation duration(From surgery completion until extubation (up to 24 hours))
- Hemodynamic stability (MAP)(30 minutes post-midazolam administration)
研究者
Hongmei Xuan
Principal Investigator
Zhuji People's Hospital of Zhejiang Province