Combined Colloids And Crystalloids Versus Crystalloids in Women With Preeclampsia Undergoing Cesarean Delivery Under Spinal Anesthesia: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- Total urine output at 2 hours post-spinal
研究概览
简要总结
This study will compare between combination of colloids/crystalloids and crystalloids in women with preeclampsia undergoing elective cesarean delivery under spinal anesthesia
详细描述
This randomized, controlled, double blind study will be conducted on women with preeclampsia with singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Immediately, after spinal anesthesia administration, patients will receive either 250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes (Combination group) or 250 mL crystalloid over 5 minutes followed by 500 mL over 55 minutes then 250 mL over 60 minutes (Crystalloid group). The studied maternal outcomes will be the urine output, ephedrine requirement, incidence of hypotension, inferior vena cava diameters, nausea/vomiting and bradycardia. Neonatal Apgar scores will be recorded at 1 and 5 minutes post-delivery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Preeclampsia: Blood Pressure ≥140/90 mmHg after 20 weeks' gestation and proteinuria ≥300 mg/24 hours or 1+ on urine dipstick
- •Singleton pregnancy
- •Elective cesarean delivery under spinal anesthesia
排除标准
- •Height <150 cm
- •Weight <60 kg
- •Body mass index ≥45 kg/m2
- •Women presenting in labor
- •Contraindications to spinal anesthesia (increased intracranial pressure or local skin infection)
- •Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
- •Preoperative administration of intravenous hydralazine or magnesium sulphate
- •Hemoglobin <10 gm/dL
- •International Normalized Ratio >1.3
- •Platelet count <100,000 /mm3
- •Preoperative serum creatinine >1.1 mg/dL
研究组 & 干预措施
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Spinal Anesthesia (Procedure)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Intrathecal Bupivacaine (Drug)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Intrathecal Fentanyl (Drug)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Cesarean Delivery (Procedure)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Ultrasound Assessment of the Inferior Vena Cava (Radiation)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: 250 mL Colloid over 5 minutes (Drug)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: 500 mL Crystalloid over 55 minutes (Drug)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: 250 mL Colloid over 60 minutes (Drug)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Intravenous Ephedrine (Drug)
Combination
250 mL colloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL colloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Intravenous Syntocinon (Drug)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Spinal Anesthesia (Procedure)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Intrathecal Bupivacaine (Drug)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Intrathecal Fentanyl (Drug)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Cesarean Delivery (Procedure)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Ultrasound Assessment of the Inferior Vena Cava (Radiation)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: 250 mL Crystalloid over 5 minutes (Drug)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: 500 mL Crystalloid over 55 minutes (Drug)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: 250 mL Crystalloid over 60 minutes (Drug)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Intravenous Ephedrine (Drug)
Crystalloid
250 mL crystalloid over 5 minutes followed by 500 mL crystalloid over 55 minutes then 250 mL crystalloid over 60 minutes. Cesarean delivery performed under spinal anesthesia (intrathecal bupivacaine 12.5 mg and intrathecal fentanyl 15 μg). Ultrasound assessment of the Inferior vena cava diameter. Intravenous ephedrine and intravenous syntocinon will be administered.
干预措施: Intravenous Syntocinon (Drug)
结局指标
主要结局
Total urine output at 2 hours post-spinal
时间窗: 2 hours after intrathecal injection
次要结局
- Number of patients requiring ephedrine(Intraoperative)
- Incidence of nausea and/or vomiting(Intraoperative)
- Incidence of bradycardia(Intraoperative)
- Maximum and minimum inferior vena cava diameters(Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal)
- Inferior vena cava collapsibility index(Baseline, at 5 minutes post-spinal, immediately after delivery of the fetus, and at 1 and 2 hours post-spinal)
- Neonatal Apgar score(At 1 and 5 minutes after delivery)
- Urine output at 1 hour post-spinal(1 hour after intrathecal injection)
- Incidence of oliguria(2 hours after intrathecal injection)
- Total ephedrine dose(Intraoperative)
- Number of patients requiring ephedrine pre-delivery(From intrathecal injection until delivery)
- Pre-delivery ephedrine dose(From intrathecal injection until delivery)
研究者
Mohamed Mohamed Tawfik
Lecturer, Department of anesthesia and surgical intensive care, Primary investigator
Mansoura University