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

Sponsor

Seoul National University Bundang Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04979039

Collaborator

(none)

Enrollment

Location

Anticipated Duration (Months)

2.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Other: analgesia nociception index (ANI) monitoring

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Aug 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2022

Anticipated Study Completion Date :

Dec 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
normal pregnancy Adult pregnant women scheduled for cesarean section under spinal anesthesia	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.

Arm

Intervention/Treatment

normal pregnancy

Adult pregnant women scheduled for cesarean section under spinal anesthesia

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.

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Seoul National University Bundang Hospital	Seongnam	Gyeonggi	Korea, Republic of	13620

Sponsors and Collaborators

Seoul National University Bundang Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Hyo-Seok Na, Clinical professor, Seoul National University Bundang Hospital

ClinicalTrials.gov Identifier:

NCT04979039

Other Study ID Numbers:

HRV Csec Spinal HypoT

First Posted:

Jul 27, 2021

Last Update Posted:

Aug 26, 2021

Last Verified:

Aug 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Aug 26, 2021