Ignite Creation Date:
2024-05-06 @ 5:13 PM
Last Modification Date:
2024-10-26 @ 2:24 PM
Study NCT ID:
NCT05230641
Status:
COMPLETED
Last Update Posted:
2023-07-07
First Post:
2022-01-12
Brief Title:
Cardiac Autonomic Dysfunction and Perioperative Outcomes
Sponsor:
National Institute of Mental Health and Neuro Sciences India
Organization:
National Institute of Mental Health and Neuro Sciences India
Study Overview
Official Title:
Cardiac Autonomic Dysfunction and Perioperative Outcomes After Neurosurgery
Status:
COMPLETED
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CADPONS
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
Detailed Description:
Demographic and baseline clinical data including comorbid conditions and medication history will be collected Baseline hemodynamic parameters - heart rate HR and systolic diastolic and mean blood pressure SBP DBP MAP rate pressure product RPP calculated as the product of HR and SBP and ANSindex which informs the degree of dysautonomia and is derived noninvasively from a recording of 572 R wave to R wave intervals on an electrocardiogram will be recorded in the immediate preoperative period
Assessment of risk factors for preoperative CAD The investigators will explore potential risk factors for CAD in neurosurgical patients The investigators postulate some known factors such as anxiety which will be diagnosed using the Visual analog scale for anxiety VAS-A age gender neurosurgical pathology site-specific surgery high cervical pathology structural brain lesions brainstem lesion etc pre-existing diabetes mellitus and hypertension and medications used for their treatment higher American Society of Anesthesiology ASA grade etc to be associated with CAD in neurosurgical patients
The investigators will explore the association between CAD and perioperative outcomes Major Adverse Cardiac Events during Intra and postoperative period in-hospital mortality and duration of postoperative ICU and hospital stay
Anesthesia will be administered as per the existing practice Hemodynamic parameters HR SBP DBP MAP at following time points - before and 1 and 2 min after induction of general anesthesia before and at 1 3 and 5 mins after tracheal intubation and before and at 1 3 and 5 mins after skull pin application where applicable Adverse hemodynamic events - persistent hypotension arrhythmias myocardial ischemia cardiac failure cardiac arrest during the early after anesthetic induction and before surgical incision late surgical incision to surgical closure intraoperative period recovery period end of anesthesia to discharge from the operating room post-anesthesia care unit PACU period from arrival to discharge from PACU and early postoperative period up to 72 hours after surgery neurological status Glasgow Coma Scale at hospital discharge and duration of ICU and hospital stay will be recorded The core temperature will be monitored during the intraoperative period to detect hypothermia 35o C or hyperthermia 375 o C
Sample size and statistical analysis Previous studies in the non-neurosurgical populations have determined the prevalence of CAD to vary from 25 to 73 Considering an average prevalence of 50 in the neurosurgical population and a possible 5 margin of error a sample size of 383 would be necessary for achieving a 95 confidence level Hence the investigators plan to recruit 400 patients over a period of 1 year to account for potential dropouts from the study
Data will be analyzed using Statistical Package for the Social Sciences SPSS or R software Continuous variables will be compared by t-test qualitative data by chi2 test or Fisher exact test Logistic regression will be used to identify the risk factors for cardiac autonomic dysfunction A p 005 will be considered statistically significant
Assessment of risk factors for preoperative CAD The investigators will explore potential risk factors for CAD in neurosurgical patients The investigators postulate some known factors such as anxiety which will be diagnosed using the Visual analog scale for anxiety VAS-A age gender neurosurgical pathology site-specific surgery high cervical pathology structural brain lesions brainstem lesion etc pre-existing diabetes mellitus and hypertension and medications used for their treatment higher American Society of Anesthesiology ASA grade etc to be associated with CAD in neurosurgical patients
The investigators will explore the association between CAD and perioperative outcomes Major Adverse Cardiac Events during Intra and postoperative period in-hospital mortality and duration of postoperative ICU and hospital stay
Anesthesia will be administered as per the existing practice Hemodynamic parameters HR SBP DBP MAP at following time points - before and 1 and 2 min after induction of general anesthesia before and at 1 3 and 5 mins after tracheal intubation and before and at 1 3 and 5 mins after skull pin application where applicable Adverse hemodynamic events - persistent hypotension arrhythmias myocardial ischemia cardiac failure cardiac arrest during the early after anesthetic induction and before surgical incision late surgical incision to surgical closure intraoperative period recovery period end of anesthesia to discharge from the operating room post-anesthesia care unit PACU period from arrival to discharge from PACU and early postoperative period up to 72 hours after surgery neurological status Glasgow Coma Scale at hospital discharge and duration of ICU and hospital stay will be recorded The core temperature will be monitored during the intraoperative period to detect hypothermia 35o C or hyperthermia 375 o C
Sample size and statistical analysis Previous studies in the non-neurosurgical populations have determined the prevalence of CAD to vary from 25 to 73 Considering an average prevalence of 50 in the neurosurgical population and a possible 5 margin of error a sample size of 383 would be necessary for achieving a 95 confidence level Hence the investigators plan to recruit 400 patients over a period of 1 year to account for potential dropouts from the study
Data will be analyzed using Statistical Package for the Social Sciences SPSS or R software Continuous variables will be compared by t-test qualitative data by chi2 test or Fisher exact test Logistic regression will be used to identify the risk factors for cardiac autonomic dysfunction A p 005 will be considered statistically significant
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None