Intrathecal Bupivacaine With or Without Dexmetomidine for Cesserian Delivery ;Arandomized Non - Inferiority Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- the duration of sensory block
研究概览
简要总结
Cesarean section (CS) is one of the most frequently performed surgical procedures globally, with an increasing demand for safe and effective anesthesia techniques. Regional anesthesia, particularly intrathecal anesthesia, has become the method of choice for elective cesarean deliveries.The most commonly used local anesthetic for intrathecal anesthesia is bupivacaine.Recent studies have focused on adjunctive agents to enhance the efficacy of local anesthetics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 35 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •(1) Full-term pregnant women undergoing elective cesarean section under spinal anesthesia. (2) Age: 20 ~ 35 years. (3) ASA physical status II ~ III
排除标准
- •Multiple pregnancies.
- •Cardiovascular disease(e.g., pre-eclampsia and hypertension).
- •Serious hepatic dysfunction (Child-Pugh class C).
- •serious renal dysfunction (undergoing dialysis before surgery).
- •History of alcohol or opioid addiction.
- •Contraindication to spinal anesthesia.
- •Refusing to sign informed consent.
研究组 & 干预措施
Group (BD)
will receive 9 mg (1.8 ml) of 0. 5% bupivacaine, with 5 μg of DEX in 0.5ml of normal saline in total volume 2.5 ml.
干预措施: Bupivacaine and Dexmedetomidine (Drug)
Group (B)
will receive intra-thecal hyperbaric bupivacaine 11 mg(2.2 ml) of 0.5% bupivacaine, with 0.5 ml of normal saline in total volume 2.5 ml.
干预措施: Bupivacaine (Drug)
结局指标
主要结局
the duration of sensory block
时间窗: after anesthesia up to 12 hours postoperatively
time taken from intrathecal injection to sensory regression to S1 dermatome.
次要结局
- the onset time of sensory block(during 30 minutes after intrathecal injection)
- the onset time of motor block(during 30 minutes after intrathecal injection)
- The recovery quality of parturients(24 hours post-operatively)
研究者
Fatma Ahmed Abdel Fatah
Assistant professor
Benha University