Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension

Recruiting

• Conditions: Cesarean Section; Spinal Anesthesia
• Interventions: Other: observation

• Registration Number: NCT06327165
• Lead Sponsor: Yonsei University

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 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-03
• Study First Submitted: 2024-03-13
• Study Start: 2024-03-18
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-25
• Last Update Submitted: 2024-03-25
• Last Update Posted: 2024-03-27
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
pregnant women	observation	Women undergoing cesarean section under spinal anesthesia with ANI monitor applied

Primary Outcome Measures

Name	Time	Method
predictive value of ANI monitor for spinal hypotension during cesarean delivery	the occurence of hypotension at (within) 1 hour after spinal anesthesia	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.

Secondary Outcome Measures

Name	Time	Method
Optimal cutoff value of ANI level for predicting occurrence of hypotension	the occurence of hypotension at (within) 1 hour after spinal anesthesia	Investigators will determine the optimal cutoff value of ANI level for predicting hypotension after spinal anesthesia.

Trial Locations

Locations (1)

Yonsei University Health system, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of