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

January 23, 2025 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult pregnant women scheduled for cesarean section under spinal anesthesia

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
normal pregnancy
Adult pregnant women scheduled for cesarean section under spinal anesthesia
Other: analgesia 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
15 min, 10 min and 5 min before entering the operating room; every 5 min after entering the operating room
Total dose of injected phenylephrine
Time Frame: During the anesthesia (from initiation of anesthesia until the end of anesthesia)
During the anesthesia (from initiation of anesthesia until the end of anesthesia)
Total dose of injected glycopyrrolate
Time Frame: During the anesthesia (from initiation of anesthesia until the end of anesthesia)
During the anesthesia (from initiation of anesthesia until the end of anesthesia)
The change of systolic blood pressure
Time Frame: Every 1 min after entering the operating room until finishing the operation
Every 1 min after entering the operating room until finishing the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2021

Primary Completion (Actual)

June 30, 2023

Study Completion (Actual)

December 28, 2024

Study Registration Dates

First Submitted

June 30, 2021

First Submitted That Met QC Criteria

July 15, 2021

First Posted (Actual)

July 27, 2021

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 23, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HRV Csec Spinal HypoT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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