Norepinephrine Versus Ephedrine for Treatment of Hypotension During Spinal Anesthesia for Caesarean Section
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 主要终点
- number of injections
研究概览
简要总结
Prospective, randomized study, including full term parturients scheduled for caesarean section under spinal anesthesia. Spinal anesthesia was performed in sitting position with a 25 G spinal needle and all patients received 15 ml/kg of crystalloid intravenously during the spinal block. Baseline hemodynamics: heart rate, systolic and diastolic blood pressure were recorded before spinal anesthesia and intraoperatively. Postspinal hypotension, defined as decrease of Systolic blood pressure>20% from the baseline value, was managed using Ephedrine increments 6 mg/3min in patients of GE group or by 5 mcg Norepinephrine/3min for the patients of GN group. Intraoperative hemodynamic data of the 2 groups were compared.
详细描述
Prospective, randomized study including full term parturients scheduled for caesarean section under spinal anesthesia. All patients were ASA status I/II and patients with arrhythmia were excluded. Spinal anesthesia was performed in sitting position at L3-4 or L4-5. A 25 G spinal needle was used for intrathecal injection of 8 mg of hyperbaric bupivacaine, 2.5 mcg sufentanil and 100 mcg morphine. All patients received 15 ml/kg of crystalloids intravenously during the spinal block. Patients were positioned in left lateral tilt position. Baseline hemodynamics; HR, systolic (SBP) and diastolic blood pressure (DPB) were recorded before spinal anesthesia and intraoperatively (every 2 min). Post anesthesia hypotension was defined as decrease of SBP>20% from the baseline value. If hypotension occurred, patients were randomized into 2 groups:
- GE group in which hypotension were managed using ephedrine increments of 6 mg Ephedrine every 3 min until correction of SBP
- GN group: patients of this group received 5mcg of Norepinephrine/3 min demographic and hemodynamic data of the two groups were compared.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Fully term parturients
- •Caesarean section under spinal anesthesia
- •ASA status I or II
排除标准
- •Severe cardiac disease
- •Cardiac arrhythmia
研究组 & 干预措施
Norepinephrine group
Treatment of the postspinal anesthesia hypotension by administrating 5 mcg of Norepinephrine intravenously every 3 min until normal systolic blood pressure
干预措施: Norepinephrine (Drug)
Ephedrine group
Management of the post spinal hypotension by administrating 6 mg of Ephedrine intravenously every 3 min
干预措施: Ephedrine (Drug)
结局指标
主要结局
number of injections
时间窗: number of injections required in the first hour
number of injections required to manage the post spinal hypotension
次要结局
未报告次要终点
研究者
Mhamed Sami Mebazaa
Professor, head of the anesthesia and ICU departement
Mongi Slim Hospital