Comparison of Fractionated Versus Bolus Administration of Different Doses of Hyperbaric Bupivacaine Combined With Opioids in Spinal Anesthesia for Caesarean Section - A Prospective, Randomized, Single Blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 99
- 试验地点
- 1
- 主要终点
- Hemodynamic Stability (systolic, diastolic and mean arterial pressure, heart rate)
研究概览
简要总结
This study aimed to compare the effectiveness and safety of fractionated versus bolus administration of different doses of hyperbaric bupivacaine (0.06 and 0.07 mg/cm height) combined with opioids in spinal anesthesia for cesarean section, with detailed evaluation of maternal hemodynamic effects, block characteristics and side effects.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •singleton full-term pregnancy scheduled for cesarean section under spinal anesthesia
- •ASA physical status II-III
- •age 18-50 years
- •height from 140 to 180 cm
- •body weight from 40 to 130 kg
排除标准
- •patient refusal
- •contraindications to spinal anesthesia
- •allergy to amide-type local anesthetics
结局指标
主要结局
Hemodynamic Stability (systolic, diastolic and mean arterial pressure, heart rate)
时间窗: Perioperative/Periprocedural - before spinal anesthesia and then during the cesarean section until its completion
Hemodynamic parameters were recorded every 2 minutes for 10 minutes, then every 5 minutes until 30 minutes, then every 15 minutes until surgery completion.
次要结局
- Spinal block characteristics (sensory block level and duration, motor block duration, analgesia duration)(Perioperative/Periprocedural)
研究者
Kateryna Bielka
Prof.
Bogomolets National Medical University