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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-50
SponsorPeking University Shenzhen Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.

Informed consent was obtained from all participants.

Disqualifiers

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.

Trial population

Singleton pregnant women aged ≥18 years with gestational age ≥37 weeks, scheduled for cesarean section.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Standard clinical spinal anesthesia and routine intraoperative monitoring

    Procedure/Surgery

    All participants receive routine clinical spinal anesthesia, standard surgical operation and conventional vital sign monitoring without additional experimental intervention. No new drugs, devices or invasive operations are applied in this study.

Treatment groups

No treatment groups listed

Trial outcomes

Primary outcomes

1

Incidence of hypotension

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

Time frame
from spinal anesthesia induction to fetal delivery

Secondary outcomes

Other outcomes

Sponsors and contacts

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