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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04979039
Other study ID # HRV Csec Spinal HypoT
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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