Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-18

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Cesarean Section Spinal Anesthesia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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pregnant women

Women undergoing cesarean section under spinal anesthesia with ANI monitor applied

observation

Intervention Type OTHER

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

Interventions

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observation

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes