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

Completed

• Conditions: Cesarean Section
• Interventions: Other: analgesia nociception index (ANI) monitoring

• Registration Number: NCT04979039
• Lead Sponsor: Seoul National University Bundang Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-30
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-27
• Study Start: 2021-08-01
• Primary Completion: 2023-06-30
• Study Completion: 2024-12-28
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-23
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
normal pregnancy	analgesia nociception index (ANI) monitoring	Adult pregnant women scheduled for cesarean section under spinal anesthesia

Primary Outcome Measures

Name	Time	Method
The change of averaged value	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	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	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

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of