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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

NCT07689825 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 145

Last updated 2026-07-27

No results posted yet for this study

Summary

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.

Conditions

  • Cesarean Section

Interventions

PROCEDURE

Standard clinical spinal anesthesia and routine intraoperative monitoring

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.

Sponsors & Collaborators

  • Peking University Shenzhen Hospital

    lead OTHER

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2026-09-30
Completion
2027-07-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07689825 on ClinicalTrials.gov