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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04979039
• Other study ID #: HRV Csec Spinal HypoT
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: August 2021
• Source: Seoul National University Bundang Hospital
• Contact: Hyo-Seok Na
• Phone: +821087012913
• Email: hsknana[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section
• Hypotension

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Total dose of injected phenylephrine		During the anesthesia (from initiation of anesthesia until the end of anesthesia)
Primary	Total dose of injected glycopyrrolate		During the anesthesia (from initiation of anesthesia until the end of anesthesia)
Primary	The change of systolic blood pressure		Every 1 min after entering the operating room until finishing the operation