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Search / Trial NCT06327165

Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension

Launched by YONSEI UNIVERSITY · Mar 21, 2024

Trial Information

Current as of July 23, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is studying a device called the ANI monitor, which measures changes in heart rate to help predict low blood pressure (hypotension) during cesarean sections performed under spinal anesthesia. Low blood pressure is a common issue in these procedures, affecting 50-70% of patients, and it can happen quickly and severely. By using the ANI monitor alongside a medication called phenylephrine, which helps maintain blood pressure, the researchers hope to see if this device can effectively alert doctors before blood pressure drops too low.

To be eligible for this trial, participants must be women who are at full term and scheduled for a cesarean delivery. However, those with certain medical conditions, such as severe obesity or specific heart issues, or who are having emergency surgeries, cannot participate. If you join the study, you will be monitored closely during your surgery, and the results may help improve care for future patients undergoing similar procedures.

Gender

FEMALE

Eligibility 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

About Yonsei University

Yonsei University, a prestigious institution located in South Korea, is renowned for its commitment to advancing medical research and education. As a clinical trial sponsor, Yonsei University leverages its extensive expertise and innovative approaches in various fields of medicine to conduct rigorous clinical trials aimed at improving patient outcomes and advancing healthcare solutions. The university's robust infrastructure, multidisciplinary collaboration, and adherence to ethical standards ensure the integrity and reliability of its research initiatives, making it a key player in the global clinical research landscape.

Locations

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported