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Clinical Trials/NCT04979039
NCT04979039
Completed
Not Applicable

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

Seoul National University Bundang Hospital1 site in 1 country50 target enrollmentAugust 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cesarean Section
Sponsor
Seoul National University Bundang Hospital
Enrollment
50
Locations
1
Primary Endpoint
The change of averaged value
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 1, 2021
End Date
December 28, 2024
Last Updated
last year
Study Type
Observational
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Hyo-Seok Na

Clinical professor

Seoul National University Bundang Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

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

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

Total dose of injected phenylephrine

Time Frame: 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)

The change of systolic blood pressure

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

Study Sites (1)

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