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Cardiac Autonomic Dysfunction and Perioperative Outcomes

NCT05230641 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 400

Last updated 2023-07-07

No results posted yet for this study

Summary

The autonomic nervous system (ANS) is cardinal for maintaining systemic homeostasis and is pivotal for the baseline regulation and modulation of vital cardiovascular, hemodynamic, respiratory, gastrointestinal, and body temperature regulating functions. Pathological perturbations of the ANS leading to cardiac dysautonomia (CAD) affect one in 1000 population. Autonomic dysfunction can occur from a variety of pathological conditions such as ischemic heart disease, systemic hypertension, diabetes mellitus, neurological illnesses, neurotrauma, and cervical spine diseases. When patients with dysautonomia present for surgical procedures, they may manifest severe hemodynamic responses that may be less responsive to pharmacological interventions. Pre-existing autonomic dysfunction accentuates perioperative hemodynamic fluctuations during stressful events like direct laryngoscopy, endotracheal intubation, and extubation, and can result in major adverse cardiac events (MACE). The complications arising from CAD can prolong the duration of hospital stay and contribute to morbidity and mortality. Preoperative diagnosis of CAD helps in anticipation of and preparation for potentially severe adverse events in the perioperative period. Most neurosurgical patients are not candidates for detailed ANS examination in the supine and standing positions due to their underlying neurological condition. Real-time assessment of heart rate variability (HRV) using the ANSiscope equipment provides information on the sympathovagal balance during the immediate preoperative period and aids in the simple rapid bedside assessment of CAD. This study aims to examine the incidence of CAD through HRV assessment in neurosurgical patients, identify the potential risk factors for CAD in this population, and evaluate the impact of CAD on perioperative outcomes.

Conditions

  • Neurosurgical Patients

Interventions

OTHER

No intervention

This is a prospective observational study

Sponsors & Collaborators

  • Vision Group on Science and Technology

    collaborator UNKNOWN

  • DyAnsys, Inc.

    collaborator INDUSTRY

  • National Institute of Mental Health and Neuro Sciences, India

    lead OTHER

Principal Investigators

  • Sangeetha RP · National Institute of Mental Health and Neuro Sciences, India

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-01
Primary Completion
2023-03-31
Completion
2023-03-31

Countries

  • India

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05230641 on ClinicalTrials.gov