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

NCT04979039 | Completed

• 1 other identifier: HRV Csec Spinal HypoT
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section

Outcome Measures

Primary Outcomes (5)

• The change of averaged value

  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

  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

  During the anesthesia (from initiation of anesthesia until the end of anesthesia)

• Total dose of injected glycopyrrolate

  During the anesthesia (from initiation of anesthesia until the end of anesthesia)

• The change of systolic blood pressure

  Every 1 min after entering the operating room until finishing the operation

Study Arms (1)

normal pregnancy

Adult pregnant women scheduled for cesarean section under spinal anesthesia

Other: analgesia nociception index (ANI) monitoring

Interventions

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.

normal pregnancy

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult pregnant women scheduled for cesarean section under spinal anesthesia

You may qualify if:

• Adult pregnant women scheduled for cesarean section under spinal anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Bundang Hospital: lead

Study Sites (1)

Seoul National University Bundang Hospital

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

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical professor

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 27, 2021
• Study Start: August 1, 2021
• Primary Completion: June 30, 2023
• Study Completion: December 28, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Locations

KR (1)