Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06327165
Status:
RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-13
Brief Title:
Predictability of ANI Analgesia Nociception Index for Spinal Hypotension
Sponsor:
Yonsei University
Organization:
Yonsei University
Study Overview
Official Title:
Predictability of ANI Analgesia Nociception Index for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Spinal anesthesia is widely accepted as the anesthetic method of choice for Cesarean section However the incidence of spinal hypotension is 50-70 and the decrease in blood pressure is often rapid and severe Heart rate variability is influenced by various factors such as the sympathetic nervous system parasympathetic nervous system temperature regulation baroreflex and endocrine regulation but high frequency heart rate variability above 015 Hz very specifically reflects the parasympathetic nervous system The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system This study aims to determine whether ANI monitor can predict hypotension in patients undergoing a caesarean section under spinal anaesthesia while applying the preemptive vasopressor phenylephrine infusion protocol
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None