CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 400 enrolled
Drug / intervention
No interventionother
Likely dose
Not stated in record
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Search/NCT05230641
NCT05230641N/ACompleted

Cardiac Autonomic Dysfunction and Perioperative Outcomes After Neurosurgery

National Institute of Mental Health and Neuro Sciences, India·observational·Posted Feb 9, 2022·Updated Jul 7, 2023

In Brief

An observational study evaluating No intervention for Neurosurgical Patients. Completed, enrolled 400 participants across 1 site.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesIndia

Timeline

N/ACompletedFinished
20222023202420252026
First PostedFeb 9, 2022
Enrollment StartMar 1, 2022
Primary CompletionMar 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.4 years ago

Interventions

No interventionother

This is a prospective observational study