Using heart rate variability to predict low blood pressure during cesarean sections
Predictability of ANI (Analgesia Nociception Index) for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
This study is testing if a heart monitor can help predict low blood pressure in pregnant women having cesarean sections to keep them safer during surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 20 Years and up |
| Sex | Female |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT06327165 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the effectiveness of the Analgesia Nociception Index (ANI) monitor in predicting spinal hypotension in patients undergoing cesarean sections with spinal anesthesia. The study focuses on full-term parturients and employs a preemptive vasopressor infusion protocol using phenylephrine. By analyzing heart rate variability, particularly the parasympathetic nervous system's influence, the study aims to enhance patient safety during surgery. The findings could lead to improved management of blood pressure during cesarean deliveries.
Who should consider this trial
Good fit: Ideal candidates for this study are full-term parturients scheduled for elective cesarean delivery.
Not a fit: Patients who may not benefit include those undergoing emergent surgery or those with contraindications to spinal anesthesia.
Why it matters
Potential benefit: If successful, this study could significantly reduce the incidence of spinal hypotension during cesarean sections, improving patient outcomes.
How similar studies have performed: Other studies have explored heart rate variability in anesthesia management, suggesting potential for success, but this specific application with ANI monitoring is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * full-term parturients undergoing cesarean delivery Exclusion Criteria: * emergent surgery, placenta previa, Morbid obesity with a BMI ≥ 40 kg/m2, Gestational age \< 36 or ≥ 41 weeks, Contraindications to spinal anesthesia, cardiac arrhythmia, implantable pacemaker, diseases affecting the autoimmune system (such as immune disease or diabetic neuropathy), use of medications affecting ANI monitoring (antimuscarinics, alpha-agonists, beta blockers), illiteracy, or foreigners
Where this trial is running
Seoul
- Yonsei University Health system, Severance Hospital — Seoul, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Seung Hyun Kim, Associate Professor
- Email: anesshkim@yuhs.ac
- Phone: 82-2-2224-1055
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.