Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06343259
Status:
RECRUITING
Last Update Posted:
2024-04-02
First Post:
2024-03-12
Brief Title:
The Effects of General Versus Spinal Anesthesia on Postoperative Myocardial Injury
Sponsor:
Sisli Hamidiye Etfal Training and Research Hospital
Organization:
Sisli Hamidiye Etfal Training and Research Hospital
Study Overview
Official Title:
Comparison of The Effects of General Anesthesia and Spinal Anesthesia on The Development of Postoperative Myocardial Injury in Elderly Patients Undergoing Hip Surgery
Status:
RECRUITING
Status Verified Date:
2024-07
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:
None
Brief Summary:
In this prospective randomized single-blind study we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery Cardiovascular events are a leading cause of mortality and morbidity following non-cardiac surgery with myocardial injury after non-cardiac surgery MINS being a significant concern MINS characterized by asymptomatic elevation of troponin levels without accompanying ECG findings is closely associated with postoperative mortality With the increasing prevalence of comorbidities in the elderly population and the rising frequency of non-cardiac surgeries in this demographic understanding the effects of different anesthesia types on postoperative myocardial injury is crucial
Detailed Description:
Cardiovascular events constitute the leading cause of mortality and morbidity following non-cardiac surgery Myocardial Injury after Non-cardiac Surgery MINS is a condition diagnosed postoperatively characterized by asymptomatic troponin elevation alone Distinguishing it from myocardial infarction it lacks symptoms and concurrent Electrocardiography ECG findings yet it correlates closely with postoperative mortality Detection can be facilitated through troponin monitoring from preoperative period to up to 72 hours postoperatively
The Vascular Events in Noncardiac Surgery Patient Cohort Assessment VISION study designed to evaluate major vascular events in patients undergoing non-cardiac surgery reported a global prevalence of MINS at 8 with over a threefold increase in 30-day mortality The diagnostic threshold for MINS as determined by the VISION study is a non-Hs troponin T level of 003 ngmL
With the increasing elderly population burdened with comorbidities globally the frequency of non-cardiac surgeries in elderly patients has risen Despite advancements in surgical and anesthetic fields the incidence of MINS and associated mortality continue to escalate Risk factors associated with MINS highlight age over 75 and the presence of comorbidities Orthopedic surgeries are most commonly performed in elderly patients with perioperative acute myocardial infarction MI incidence shown to increase by 31-fold in knee surgeries and 25-fold in hip surgeries Postoperative pain and opioid use in this patient group significantly contribute to overlooked myocardial ischemia
In a sub-study of the VISION trial examining cardiovascular outcomes of orthopedic surgery the incidence of MINS was reported at 119 with 30-day mortality rates of 1 in MINS-absent patients and 98 in MINS-present patients markedly higher than non-orthopedic surgeries
Several studies have identified perioperative and postoperative hypotension as the primary risk factor for MINS emphasizing the importance of anesthesia management in preventing perioperative hypotension However no study has specifically focused on the relationship between chosen anesthesia technique and the development of hypotension and MINS George R and colleagues conducted a prospective observational cohort study in India analyzing the incidence and risk factors of MINS finding a higher incidence in patients receiving peripheral nerve blocks compared to general anesthesia and spinal anesthesia particularly in patients with high cardiac comorbidities Nonetheless no significant relationship was observed between the chosen anesthesia technique and the development of MINS in the orthopedic surgery subgroup of the VISION study
In this prospective randomized single-blind study we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery
The Vascular Events in Noncardiac Surgery Patient Cohort Assessment VISION study designed to evaluate major vascular events in patients undergoing non-cardiac surgery reported a global prevalence of MINS at 8 with over a threefold increase in 30-day mortality The diagnostic threshold for MINS as determined by the VISION study is a non-Hs troponin T level of 003 ngmL
With the increasing elderly population burdened with comorbidities globally the frequency of non-cardiac surgeries in elderly patients has risen Despite advancements in surgical and anesthetic fields the incidence of MINS and associated mortality continue to escalate Risk factors associated with MINS highlight age over 75 and the presence of comorbidities Orthopedic surgeries are most commonly performed in elderly patients with perioperative acute myocardial infarction MI incidence shown to increase by 31-fold in knee surgeries and 25-fold in hip surgeries Postoperative pain and opioid use in this patient group significantly contribute to overlooked myocardial ischemia
In a sub-study of the VISION trial examining cardiovascular outcomes of orthopedic surgery the incidence of MINS was reported at 119 with 30-day mortality rates of 1 in MINS-absent patients and 98 in MINS-present patients markedly higher than non-orthopedic surgeries
Several studies have identified perioperative and postoperative hypotension as the primary risk factor for MINS emphasizing the importance of anesthesia management in preventing perioperative hypotension However no study has specifically focused on the relationship between chosen anesthesia technique and the development of hypotension and MINS George R and colleagues conducted a prospective observational cohort study in India analyzing the incidence and risk factors of MINS finding a higher incidence in patients receiving peripheral nerve blocks compared to general anesthesia and spinal anesthesia particularly in patients with high cardiac comorbidities Nonetheless no significant relationship was observed between the chosen anesthesia technique and the development of MINS in the orthopedic surgery subgroup of the VISION study
In this prospective randomized single-blind study we aim to compare the effects of general anesthesia and spinal anesthesia on postoperative myocardial injury in elderly patients undergoing hip surgery
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