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Heart Rate Variability to Predict Hypotension Following Spinal Anesthesia in Cesarean Delivery

Heart Rate Variability Monitoring to Predict Hypotension Following Spinal Anesthesia for Cesarean Delivery: Prospective Observational Study

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04979039
Enrollment
50
Registered
2021-07-27
Start date
2021-08-01
Completion date
2024-12-28
Last updated
2025-01-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Brief summary

Based on the patient's heart rate variability, the analgesia nociception index (ANI) measures the activity of the autonomic nervous system and the sympathetic/parasympathetic nervous system and expresses it as a numerical value through a specific algorithm. The investigators will analyze it and see if it has the ability to predict severe hypotension following spinal anesthesia.

Interventions

OTHERanalgesia nociception index (ANI) monitoring

The ANI monitor starts lying on the bed in the waiting area before entering the operating room, and the monitoring period should be at least 15 minutes. After entering the operating room, monitoring begins again and is maintained during the operation.

Sponsors

Seoul National University Bundang Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Adult pregnant women scheduled for cesarean section under spinal anesthesia

Exclusion criteria

* Emergency cesarean section * When performing general anesthesia or epidural anesthesia * Multiple pregnancies * Surgery in which massive hemorrhage and massive blood transfusion are expected due to placenta previa * Cardiac arrhythmias, congestive heart failure, ischemic heart disease, congenital heart anomalies * Cranial nervous system disease * Autonomic nervous system-related underlying diseases not related to pregnancy * Fetal malformations * Those who have an allergic skin reaction to adhesive substances such as bandages

Design outcomes

Primary

MeasureTime frameDescription
The change of averaged value15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating roomThe change of averaged value presented in ANI monitor
The change of instantaneous value15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating roomThe change of instantaneous value presented in ANI monitor
Total dose of injected phenylephrineDuring the anesthesia (from initiation of anesthesia until the end of anesthesia)
Total dose of injected glycopyrrolateDuring the anesthesia (from initiation of anesthesia until the end of anesthesia)
The change of systolic blood pressureEvery 1 min after entering the operating room until finishing the operation

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026