Colloid Preload Versus Crystalloid Co-load in Cesarean Section Under Spinal Anesthesia Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 127
- 主要终点
- The primary outcome was the incidence of hypotension
研究概览
简要总结
Comparison between colloid preload and crystalloid co-load in cesarean section under spinal anesthesia.
- The primary outcome was the incidence of hypotension
- Secondary outcomes included the incidence of severe hypotension, total ephedrine dose, nausea and vomiting and neonatal outcome assessed by Apgar scores and umbilical artery blood gas analysis
详细描述
It's a prospective randomized study, during 7 months between march and September 2016, carry on department of anesthesia and intensive care and department of obstetrics and gynecology, at Taher Sfar Mahdia University Hospital. investigators included participants:
- Aged between 18 and 40 years' old
- American Society of Anesthesiologists physical status I or II (ASA)
- Full-term singleton pregnancy
- scheduled for elective cesarean section under spinal anesthesia
Parturients were excluded if :
- participants younger than 18 or older than 40 years
- cardiovascular, cerebrovascular or renal disease
- multiple gestations
- polyhydramnios or known fetal abnormalities
- allergy to local anesthetics or opioids
- emergency Cesarean section or parturient that have failed vaginal delivery with epidural analgesia
- contraindications for performing spinal anesthesia in this study no premedication was given. Patients entered the operating room and lay supine with 15° of left lateral tilt on the operating table.
Standard monitors of electrocardiography, pulse oximetry (Spo2), and noninvasive blood pressure were applied on the right arm.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Aged between 18 and 40 years' old
- •American Society of Anesthesiologists physical status I or II (ASA)
- •Full-term singleton pregnancy
- •scheduled for elective cesarean section under spinal anesthesia
排除标准
- •cardiovascular, cerebrovascular or renal disease
- •multiple gestations
- •polyhydramnios or known fetal abnormalities
- •allergy to local anesthetics or opioids
- •emergency Cesarean section or parturient that have failed vaginal delivery with epidural analgesia
- •contraindications for performing spinal anesthesia
研究组 & 干预措施
colloid preload
Group CoP: group with colloid preload The preload group received rapid infusion of 15ml/kg of 6% hydroxyethyl starch (6% HES) administered by gravity at a wide-open rate over a period of 15-30min before induction of spinal anesthesia.
干预措施: colloid preload (Drug)
crystalloid coload
Group CrC: group with crystalloid coload The coload group received a sodium chloride 0.9% perfusion as rapidly as possible starting at the time of intrathecal injection for spinal anesthesia.
干预措施: colloid preload (Drug)
结局指标
主要结局
The primary outcome was the incidence of hypotension
时间窗: 2 hours
hypotension defined by decreasing of arterial blood pressure under 20% of base line
次要结局
- neonatal outcome(2 hours)
- nausea and vomiting(2 hours)
- incidence of severe hypotension(2 hours)
- total ephedrine dose(2 hours)
研究者
Majdoub Ali MD
head of anesthesia department clinical professor
University Hospital, Mahdia