Incidence of Post-Spinal Anaesthesia Hypotension in Caesarean Delivery: A Randomized Trial of Classic Versus Sequential Spinal Technique
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 94
- 试验地点
- 1
- 主要终点
- Incidence of post-spinal hypotension
研究概览
简要总结
Given the clinical importance of maternal hypotension, the potential advantages of sequential spinal dosing warrant formal evaluation in a prospective, adequately powered randomized controlled trial. We therefore designed this study to compare the incidence of post-spinal hypotension between the classic single-shot spinal and the sequential fractionated spinal techniques in elective cesarean delivery.
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
- Double (Participant, Outcomes Assessor)
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
- •Adult women aged 18-45 years.
- •ASA physical status II-III.
- •Scheduled for elective cesarean section under standardized spinal anesthesia.
排除标准
- •Allergy to local anesthetics.
- •Emergency cesarean section.
- •Contraindication to spinal anesthesia (e.g., coagulopathy, infection at the puncture site).
- •Preexisting hypertension on medication or pre-eclampsia with severe features.
- •Known cardiac disease accompanied by hemodynamic instability.
- •Allergy to study drugs.
- •Fetal distress or non-reassuring cardiotocography (CTG).
- •BMI >40 kg/m².
- •Refusal to sign informed consent.
研究组 & 干预措施
Classic group
In the classic group, patients will receive a total intrathecal dose of 12.5 mg hyperbaric bupivacaine 0.5% (2.5 mL) combined with fentanyl 20 µg, administered as a single injection. Immediately after completion of the injection, the patient will be positioned supine with a 15° left lateral tilt to minimize aortocaval compression and facilitate uniform spread of the anesthetic solution.
干预措施: Classic group (Procedure)
Sequential group
In the sequential (fractionated) group, patients will receive the intrathecal dose in two fractions. While in the sitting position, the first fraction consisting of 7.5 mg (1.5 mL) of hyperbaric bupivacaine 0.5% combined with fentanyl 15 µg will be administered. After waiting for 60 seconds, the remaining 5 mg (1 mL) of hyperbaric bupivacaine and an additional 5 µg of fentanyl will be injected, either through the same intrathecal needle (if kept in place) or following careful reinsertion according to institutional practice. Immediately after completing the injection, the patient will be positioned supine with a 15° left lateral tilt to optimize maternal hemodynamics and ensure even distribution of the anesthetic solution.
干预措施: Sequential group (Procedure)
结局指标
主要结局
Incidence of post-spinal hypotension
时间窗: Assessed during the first 15 minutes after the intrathecal injection.
Occurrence of maternal hypotension within 15 minutes after intrathecal injection, defined as a systolic blood pressure (SBP) decrease greater than 20% from baseline or an absolute SBP below 90 mmHg. This outcome directly measures the hemodynamic stability achieved by each spinal technique.
次要结局
- Time to first hypotensive episode(Measured continuously for 15 minutes following the intrathecal injection.)
- Number of hypotensive episodes(Assessed within 15 minutes after intrathecal injection.)
- Total vasopressor dose(Assessed within 15 minutes after spinal administration.)
- Maximal sensory block level and time to T4(Evaluated from injection until block stabilization within 20 minutes.)
- Maternal nausea and vomiting(Monitored intraoperatively up to delivery.)
- Neonatal outcomes (Apgar scores and umbilical artery pH)(Determined immediately after delivery (Apgar at 1 and 5 minutes; pH from cord sample at birth).)
- Maternal satisfaction(Assessed after delivery before discharge from recovery.)
研究者
Neveen Abd El Maksoad Kohaf
Lecturer of Clinical Pharmacy
Al-Azhar University