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临床试验/NCT07689825
NCT07689825尚未招募不适用

Development of a Risk Prediction Model for Post-Spinal Anesthesia Hypotension During Cesarean Delivery Using Heart Rate, Blood Pressure, Perfusion Index, ECG Waveforms, and SpO₂ Waveforms

Peking University Shenzhen Hospital1 个研究点 分布在 1 个国家目标入组 145 人开始时间: 2026年7月13日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
145
试验地点
1
主要终点
Incidence of hypotension

研究概览

简要总结

Spinal anesthesia is the preferred anesthetic technique for patients undergoing cesarean section. Compared with general anesthesia, spinal anesthesia offers multiple advantages. However, a common adverse effect of this technique is hypotension following spinal anesthesia, which is induced by sympathetic blockade and has an incidence rate as high as 70%. Hypotension can lead to maternal nausea and vomiting, reduced fetal Apgar scores, and acidosis, exerting adverse effects on both the mother and the fetus. Furthermore, prolonged duration of hypotension may adversely impact the fetal neurological prognosis. Therefore, predicting which patients are at high risk for developing hypotension facilitates the implementation of preventive measures-such as the administration of vasoactive agents and intensified monitoring through frequent blood pressure measurements-to improve clinical outcomes in these high-risk patients.

Patients undergoing cesarean section who met the inclusion criteria were prospectively observed. A standardized anesthesia protocol was uniformly applied to investigate the incidence of hypotension following spinal anesthesia. Based on dynamic changes in preoperative and intraoperative heart rate, blood pressure, perfusion index, and waveform characteristics of electrocardiography and pulse oximetry, a prognostic model was developed to predict the occurrence of hypotension after spinal anesthesia.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.
  • Informed consent was obtained from all participants.

排除标准

  • Emergency cesarean sections or cases requiring general anesthesia.
  • Maternal age < 18 years.
  • Major obstetric complications (e.g., placenta previa, gestational hypertension, preeclampsia) or significant cardiovascular/cerebrovascular diseases.
  • Body Mass Index (BMI) ≥ 36 kg/m².
  • Gestational age < 36 weeks or > 41 weeks.
  • Contraindications to neuraxial anesthesia.
  • Refusal to participate.

结局指标

主要结局

Incidence of hypotension

时间窗: from spinal anesthesia induction to fetal delivery

Hypotension was defined as a mean arterial pressure (MAP) \< 65 mmHg.

次要结局

未报告次要终点

研究者

发起方
Peking University Shenzhen Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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