Cardiac Autonomic Dysfunction and Perioperative Outcomes

NCT05230641 | Completed DMC

• 1 other identifier: NIMHANS/33 IEC(BS&NS DIV)/2021
• Study Type: observational
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

cardiac dysautonomia; neurosurgery; heart rate variability; hypotension; anesthesia; major adverse cardiac events; perioperative outcome

Outcome Measures

Primary Outcomes (1)

• Prevalence of cardiac autonomic dysfunction in neurosurgical patients

  To study the prevalence of cardiac autonomic dysfunction in neurosurgical patients

  Before anesthesia administration for surgery

Secondary Outcomes (7)

• Risk factors of cardiac autonomic dysfunction in neurosurgical patients

  Baseline

• Impact of cardiac autonomic dysfunction on hemodynamic stress response

  During anesthesia procedure for surgery

• Impact of cardiac autonomic dysfunction on hemodynamic instability

  During surgery

• Impact of cardiac autonomic dysfunction on Major Adverse Cardiac Events

  During and after surgery till discharge from the hospital, an average of 1 week

• Impact of cardiac autonomic dysfunction on temperature instability

  During surgery

Interventions

No intervention OTHER

This is a prospective observational study

Also known as: No interventions

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consenting patients scheduled for neurosurgical procedures at the National Institute of Mental Health and Neurosciences, Bengaluru will be recruited if they fulfill the study inclusion criteria during the period of study duration

You may qualify if:

• aged between 18 and 80 years
• belonging to ASA grade 1-4
• scheduled for craniotomies or spinal surgeries under anesthesia

You may not qualify if:

• scheduled for redo procedures
• patients with preoperative arrhythmias and cardiac failure
• patients on preoperative inotropic support
• pregnant neurosurgical patients

Sponsors & Collaborators

• National Institute of Mental Health and Neuro Sciences, India: lead
• Vision Group on Science and Technology: collaborator
• DyAnsys, Inc.: collaborator

Study Sites (1)

NIMHANS hospital

Bangalore, Karnataka, 560029, India

Location

Related Publications (13)

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  PMID: 31297663 BACKGROUND

• McGrane S, Atria NP, Barwise JA. Perioperative implications of the patient with autonomic dysfunction. Curr Opin Anaesthesiol. 2014 Jun;27(3):365-70. doi: 10.1097/ACO.0000000000000072.

  PMID: 24722004 BACKGROUND

• Keyl C, Lemberger P, Palitzsch KD, Hochmuth K, Liebold A, Hobbhahn J. Cardiovascular autonomic dysfunction and hemodynamic response to anesthetic induction in patients with coronary artery disease and diabetes mellitus. Anesth Analg. 1999 May;88(5):985-91. doi: 10.1097/00000539-199905000-00004.

  PMID: 10320156 BACKGROUND

• Polderman JAW, Sperna Weiland NH, Klaver MH, Biginski J, Horninge M, Hollmann MW, DeVries JH, Immink RV, Preckel B, Hermanides J. The prevalence of cardiovascular autonomic neuropathy and its influence on post induction hemodynamic variables in patients with and without diabetes; A prospective cohort study. PLoS One. 2018 Nov 26;13(11):e0207384. doi: 10.1371/journal.pone.0207384. eCollection 2018.

  PMID: 30475825 BACKGROUND

• Hogan AM, Luck C, Woods S, Ortu A, Petkov S. The Effect of Orthostatic Hypotension Detected Pre-Operatively on Post-Operative Outcome. J Am Geriatr Soc. 2021 Mar;69(3):767-772. doi: 10.1111/jgs.16966. Epub 2020 Dec 11.

  PMID: 33314116 BACKGROUND

• Mustafa HI, Fessel JP, Barwise J, Shannon JR, Raj SR, Diedrich A, Biaggioni I, Robertson D. Dysautonomia: perioperative implications. Anesthesiology. 2012 Jan;116(1):205-15. doi: 10.1097/ALN.0b013e31823db712.

  PMID: 22143168 BACKGROUND

• Cheshire WP, Freeman R, Gibbons CH, Cortelli P, Wenning GK, Hilz MJ, Spies JM, Lipp A, Sandroni P, Wada N, Mano T, Kim HA, Kimpinski K, Iodice V, Idiaquez J, Thaisetthawatkul P, Coon EA, Low PA, Singer W. Corrigendum to "Electrodiagnostic assessment of the autonomic nervous system: A consensus statement endorsed by the American Autonomic Society, American Academy of Neurology, and the International Federation of Clinical Neurophysiology" [Clin. Neurophysiol. 132(2) (2021) 666-682]. Clin Neurophysiol. 2021 May;132(5):1194. doi: 10.1016/j.clinph.2021.02.006. Epub 2021 Mar 6. No abstract available.

  PMID: 33685802 BACKGROUND

• Farbood A, Sahmeddini MA, Bayat S, Karami N. The effect of preoperative depression and anxiety on heart rate variability in women with breast cancer. Breast Cancer. 2020 Sep;27(5):912-918. doi: 10.1007/s12282-020-01087-y. Epub 2020 Apr 7.

  PMID: 32266603 BACKGROUND

• Abhishekh HA, Nisarga P, Kisan R, Meghana A, Chandran S, Trichur Raju, Sathyaprabha TN. Influence of age and gender on autonomic regulation of heart. J Clin Monit Comput. 2013 Jun;27(3):259-64. doi: 10.1007/s10877-012-9424-3. Epub 2013 Jan 8.

  PMID: 23297094 BACKGROUND

• Katsanos AH, Korantzopoulos P, Tsivgoulis G, Kyritsis AP, Kosmidou M, Giannopoulos S. Electrocardiographic abnormalities and cardiac arrhythmias in structural brain lesions. Int J Cardiol. 2013 Jul 31;167(2):328-34. doi: 10.1016/j.ijcard.2012.06.107. Epub 2012 Jul 16.

  PMID: 22809542 BACKGROUND

• Ideguchi M, Kajiwara K, Yoshikawa K, Sadahiro H, Nomura S, Fujii M, Suzuki M. Characteristics of intraoperative abnormal hemodynamics during resection of an intra-fourth ventricular tumor located on the dorsal medulla oblongata. Neurol Med Chir (Tokyo). 2013;53(10):655-62. doi: 10.2176/nmc.oa2012-0401. Epub 2013 Sep 27.

  PMID: 24077276 BACKGROUND

• Padley JR, Ben-Menachem E. Low pre-operative heart rate variability and complexity are associated with hypotension after anesthesia induction in major abdominal surgery. J Clin Monit Comput. 2018 Apr;32(2):245-252. doi: 10.1007/s10877-017-0012-4. Epub 2017 Mar 14.

  PMID: 28293808 BACKGROUND

• Knuttgen D, Weidemann D, Doehn M. Diabetic autonomic neuropathy: abnormal cardiovascular reactions under general anesthesia. Klin Wochenschr. 1990 Dec 4;68(23):1168-72. doi: 10.1007/BF01815272.

  PMID: 2280579 BACKGROUND

MeSH Terms

Conditions

Hypotension; Cardiovascular Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases

Study Officials

• Sangeetha RP

  National Institute of Mental Health and Neuro Sciences, India

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: January 12, 2022
• First Posted: February 9, 2022
• Study Start: March 1, 2022
• Primary Completion: March 31, 2023
• Study Completion: March 31, 2023
• Last Updated: July 7, 2023

Record last verified: 2023-07

Locations

IN (1)