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OpenTrials
Completed

NCT Number: NCT04979039

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

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.

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Key information

Conditions

Cesarean Section

Age range

20 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 13620, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

analgesia nociception index (ANI) monitoring

Other

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.

Primary outcomes

  1. The change of averaged value

    Time frame: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room

    The change of averaged value presented in ANI monitor

  2. The change of instantaneous value

    Time frame: 15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room

    The change of instantaneous value presented in ANI monitor

  3. Total dose of injected phenylephrine

    Time frame: During the anesthesia (from initiation of anesthesia until the end of anesthesia)

  4. Total dose of injected glycopyrrolate

    Time frame: During the anesthesia (from initiation of anesthesia until the end of anesthesia)

  5. The change of systolic blood pressure

    Time frame: Every 1 min after entering the operating room until finishing the operation

Sponsors and collaborators

Lead sponsor

Seoul National University Bundang Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Jul 27, 2021
Registry last updated
Jan 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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