Predictability of ANI (Analgesia Nociception Index) for Spinal Hypotension

March 25, 2024 updated by: Yonsei University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Seung Hyun Kim, Associate Professor
  • Phone Number: 82-2-2224-1055
  • Email: anesshkim@yuhs.ac

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Recruiting
        • Yonsei University Health System, Severance Hospital
        • Contact:
          • Seung Hyun Kim, Associate Professor
          • Phone Number: 82-2-2224-1055
          • Email: anesshkim@yuhs.ac

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
pregnant women
Women undergoing cesarean section under spinal anesthesia with ANI monitor applied
Other: observation
The ANI monitor calculates heart rate variability mediated by changes in the parasympathetic nervous system.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
predictive value of ANI monitor for spinal hypotension during cesarean delivery
Time Frame: 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.
the occurence of hypotension at (within) 1 hour after spinal anesthesia

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Optimal cutoff value of ANI level for predicting occurrence of hypotension
Time Frame: 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.
the occurence of hypotension at (within) 1 hour after spinal anesthesia

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yonsei University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

March 13, 2024

First Submitted That Met QC Criteria

March 21, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-2023-0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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