Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension

Cesarean Section Clinical Trial

Official title:

Predictability of ANI (Analgesia Nociception Index) for Hypotension After Spinal Anesthesia in Patients Undergoing Cesarean Section

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06327165
• Other study ID #: 1-2023-0072
• Status: Recruiting
• Start date: March 18, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Yonsei University
• Contact: Seung Hyun Kim, Associate Professor
• Phone: 82-2-2224-1055
• Email: anesshkim[@]yuhs.ac
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 0.15 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• full-term parturients undergoing cesarean delivery

Exclusion Criteria:

• emergent surgery, placenta previa, Morbid obesity with a BMI = 40 kg/m2, Gestational age < 36 or = 41 weeks, Contraindications to spinal anesthesia, cardiac arrhythmia, implantable pacemaker, diseases affecting the autoimmune system (such as immune disease or diabetic neuropathy), use of medications affecting ANI monitoring (antimuscarinics, alpha-agonists, beta blockers), illiteracy, or foreigners

Related Conditions & MeSH terms

• Cesarean Section
• Hypotension
• Spinal Anesthesia

Intervention

Other:
• observation
The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health system, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yonsei University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	predictive value of ANI monitor for spinal hypotension during cesarean delivery	Investigators will determine the predictive power of the ANI score change for the occurrence of hypotension after spinal anesthesia by drawing a receiver operating characteristic (ROC) curve of the change in ANI score (baseline value - minimum value) and calculating the area under the ROC curve.	the occurence of hypotension at (within) 1 hour after spinal anesthesia
Secondary	Optimal cutoff value of ANI level for predicting occurrence of hypotension	Investigators will determine the optimal cutoff value of ANI level for predicting hypotension after spinal anesthesia.	the occurence of hypotension at (within) 1 hour after spinal anesthesia