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

NCT ID: NCT04979039

Last Updated: 2025-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-08-01

Study Completion Date

2024-12-28

Brief Summary

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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

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Conditions

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Cesarean Section

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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normal pregnancy

Adult pregnant women scheduled for cesarean section under spinal anesthesia

analgesia nociception index (ANI) monitoring

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Bundang Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyo-Seok Na

Clinical professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

Other Identifiers

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HRV Csec Spinal HypoT

Identifier Type: -

Identifier Source: org_study_id

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