Combined Colloid Preload And Crystalloid Coload Versus Crystalloid Coload During Spinal Anesthesia for Cesarean Delivery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Total ephedrine dose
研究概览
简要总结
The study will compare one technique of fluid administration (combined colloid preload and crystalloid colaod) with another one (crystalloid coload) during elective cesarean delivery performed under spinal anesthesia.
详细描述
This randomized, controlled, double-blind study will be conducted on ASA physical status II parturients with full-term singleton pregnancy undergoing elective cesarean delivery under spinal anesthesia. Participants will receive either 500 mL colloid preload and 500 mL crystalloid coload (Combination group) or 1000 mL crystalloid coload (Coload group). Systolic blood pressure will be recorded every minute and ephedrine will be administered when hypotension occurs according to a predefined protocol. The total ephedrine dose, time to the first ephedrine dose, heart rate, inferior vena cava diameter, nausea/vomiting, and neonatal Apgar scores will be recorded.
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
- •American Society of Anesthesiologists physical status II parturients
- •Full term, singleton pregnancy
- •Elective cesarean delivery under spinal anesthesia
排除标准
- •Age <19 or > 40 years
- •Height <150 cm
- •Weight <60 kg
- •Body mass index ≥40 kg/m2
- •Contraindications to spinal anesthesia (increased intracranial pressure, coagulopathy, or local skin infection)
- •Chronic or pregnancy-induced hypertension
- •Hemoglobin <10 gm/dL.
- •Diabetes mellitus, cardiovascular, cerebrovascular, or renal disease
- •Polyhydramnios or known fetal abnormalities
研究组 & 干预措施
Combination
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
干预措施: 500 mL Colloid Preload (Drug)
Combination
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
干预措施: Spinal Anesthesia (Procedure)
Combination
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
干预措施: Intrathecal Bupivacaine (Drug)
Combination
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
干预措施: Intrathecal Fentanyl (Drug)
Combination
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
干预措施: 500 mL Crystalloid Coload (Drug)
Combination
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
干预措施: Cesarean Delivery (Procedure)
Combination
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
干预措施: Ultrasound Assessment of the Inferior Vena Cava (Radiation)
Combination
500 mL colloid preload and 500 mL crystalloid coload. 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 will be administered.
干预措施: Intravenous Ephedrine (Drug)
Coload
1000 mL crystalloid coload. 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 will be administered.
干预措施: Spinal Anesthesia (Procedure)
Coload
1000 mL crystalloid coload. 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 will be administered.
干预措施: Intrathecal Bupivacaine (Drug)
Coload
1000 mL crystalloid coload. 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 will be administered.
干预措施: Intrathecal Fentanyl (Drug)
Coload
1000 mL crystalloid coload. 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 will be administered.
干预措施: 1000 mL Crystalloid Coload (Drug)
Coload
1000 mL crystalloid coload. 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 will be administered.
干预措施: Cesarean Delivery (Procedure)
Coload
1000 mL crystalloid coload. 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 will be administered.
干预措施: Ultrasound Assessment of the Inferior Vena Cava (Radiation)
Coload
1000 mL crystalloid coload. 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 will be administered.
干预措施: Intravenous Ephedrine (Drug)
结局指标
主要结局
Total ephedrine dose
时间窗: intraoperative
次要结局
- Incidence of severe hypotension(intraoperative)
- Time to the first ephedrine dose(intraoperative)
- Heart rate(intraoperative)
- Inferior vena cava largest and smallest diameters(Baseline, at 1 and 5 minutes after intrathecal injection, delivery)
- Inferior vena cava collapsibility index(Baseline, at 1 and 5 minutes after intrathecal injection, delivery)
- Incidence of nausea and/or vomiting(intraoperative)
- Neonatal Apgar score(At 1 and 5 minutes after delivery)
- Incidence of hypotension(intraoperative)
研究者
Mohamed Mohamed Tawfik
Lecturer, Department of anesthesia and surgical intensive care, principal investigator
Mansoura University