Skip to content

Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT06327165
Enrollment
40
Registered
2024-03-25
Start date
2024-03-18
Completion date
2024-12-31
Last updated
2024-03-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section, Spinal Anesthesia

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.

Interventions

OTHERobservation

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

Sponsors

Yonsei University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
20 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
predictive value of ANI monitor for spinal hypotension during cesarean deliverythe occurence of hypotension at (within) 1 hour after spinal anesthesiaInvestigators 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

MeasureTime frameDescription
Optimal cutoff value of ANI level for predicting occurrence of hypotensionthe occurence of hypotension at (within) 1 hour after spinal anesthesiaInvestigators will determine the optimal cutoff value of ANI level for predicting hypotension after spinal anesthesia.

Countries

South Korea

Contacts

Primary ContactSeung Hyun Kim, Associate Professor
anesshkim@yuhs.ac82-2-2224-1055

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026