Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension

NCT06327165 | Recruiting DMC

• 1 other identifier: 1-2023-0072
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cesarean Section; Spinal Anesthesia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Optimal cutoff value of ANI level for predicting occurrence of hypotension

  the occurence of hypotension at (within) 1 hour after spinal anesthesia

Study Arms (1)

pregnant women

Women undergoing cesarean section under spinal anesthesia with ANI monitor applied

Other: observation

Interventions

observation OTHER

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

pregnant women

Eligibility Criteria

• Age: 20 Years+
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ANI monitor will be applied to all patients, but will be covered with black papar so that it could not be observed during anesthesia. ANI data recorded at 1 second intervals will be downloaded at the end of anesthesia.

You may qualify if:

• full-term parturients undergoing cesarean delivery

You may not qualify if:

• 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

Sponsors & Collaborators

• Yonsei University: lead

Study Sites (1)

Yonsei University Health system, Severance Hospital

Seoul, South Korea

RECRUITING

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

Methods; Investigative Techniques

Central Study Contacts

Seung Hyun Kim, Associate Professor

CONTACT

82-2-2224-1055; anesshkim@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2024
• First Posted: March 25, 2024
• Study Start: March 18, 2024
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: March 27, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)