Height Adjusted Versus Standardized Dose of Bupivacaine in Spinal Anesthesia for Caesarean Delivery - A Randomized Double-blind Interventional Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- rate of arterial hypotension
研究概览
简要总结
General anesthesia during pregnancy is associated with several major risks including unanticipated difficult airway, pulmonary aspiration, and specific anesthetic effects on the newborn. Thus, intrathecal anesthesia is the technique of choice for cesarean section.
Nevertheless, the main side effect of intrathecal anesthesia is arterial hypotension which depend mainly on the dose of local anesthetic administered intrathecally.
To date there is no guidelines nor evidences whic help the anesthetist to precisely estimate the required dose. Most often a "standardized dose" of 8 to 10 mg of bupivacaine is administered. However, some data suggest that a lower dose may be administered resulting in less frequent arterial hypotension. Nevertheless, a well designed randomized study is lacking.
详细描述
The present controlled randomized double blind trial was designed to compare 2 intrathecal dose of bupivacaine for cesarean section
- a "standard" dose of 10 mg of intrathecal bupivacaine associated with morphine 100 micrograms and sufentanil 3 micrograms
- a height-calculated dose of bupivacaine (0.05 mg per cm of height) on associated with morphine 100 micrograms and sufentanil 3 micrograms
The main outcome is the rate of hypotension defined as a 20% or more decrease in systolic arterial pressure.
Secondary outcomes focused on intrathecal anesthesia efficacy, success or failure and on interventions required to manage arterial hypotension
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Neither the patient nor the care provider nor the outcome assessor will know the allocation group.
Bupivacaine syringe will be prepare, according to the protocol, by a separate anesthetist not involved in the care of the patient. The solution in both groups will have the same volume.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •scheduled cesarean section with intrathecal anesthesia
- •term pregnancy > 35 weeks
- •signed informed consent
排除标准
- •unscheduled or emergent cesarean section
- •any contra indication to intrathecal anesthesia
- •any antihypertensive drug prescribed to control arterial pressure during pregnancy
- •pre-eclampsia and eclampsia
- •history of Marfan or Ehlers Danlos disease
结局指标
主要结局
rate of arterial hypotension
时间窗: 4 hours since the start of intrathecal bupivacaine administration
rate of arterial hypotension defined as a 20% or more decrease in systolic arterial pressure as compared with baseline systolic arterial pressure measured at 32 weeks
次要结局
- patient's comfort self evaluation(4 hours since the start of intrathecal bupivacaine administration)
- lower limb motor block at the end of the caesarean section(5 min after the end of caesarean section at newborn umbilical cord clamp)
- vasopressor total dose(4 hours since the start of intrathecal bupivacaine administration)
- rate of need for general anesthesia(5 min after the end of caesarean section at newborn umbilical cord clamp)
- metameric level of intrathecal anesthesia(4 hours since the start of intrathecal bupivacaine administration)