Clinical trial NCT05340946: Comparison of the Effect of Two Anaesthesia Methods in Preventing Perioperative Myocardial Infarcation in Patients With Cardiac Risk Undergoing Total Knee Arthroplasty
Official title: Comparison of the Effect of Two Anaesthesia Methods in Preventing Perioperative Myocardial Infarction in Patients With Cardiac Risk Undergoing Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myocardial Ischaemia
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-04-22
Enrollment: 50
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The aim of this study is to compare the effect of two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty. The primary outcome included perioperative levels of brain natriuretic peptide \& cardiac troponins. Secondary outcomes included postoperative operative pain assessment using visual analogue scale, total amount of analgesic consumption, patient satisfaction \& cardiovascular complications (myocardial infarction, arrhythmias , heart failure, hypotension, hypertension \& the need for inotropic agents ).
Primary purpose: PREVENTION

Brief summary: Comparison of the effect of two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty

Detailed description: we enrolled 50 patients of both sex of American society of Anesthesiologists (ASA) physical status II where the presence and/or risk for coronary artery disease (CAD) as well as planned lower extremity surgery was considered. Presence of CAD was ascertained by history of myocardial infarction and diagnosis of typical angina or atypical angina with a positive stress test \& ECG finding. Risk for CAD included age (\> 65 years old), hypertension, smoking habit, blood cholesterol (\>240 mg/dL), and diabetes. who met the selection criteria were randomly allocated to 1 of the 2 groups (25 patients) each:

* Group (G): received general anaesthesia followed by IV patient-controlled analgesia (IV PCA).
* Group (F): received spinal anaesthesia followed by continuous ultrasound guided femoral never block once the anaesthesia-induced motor block resolved. We aimed to compare the effect of the two anaesthesia methods in preventing perioperative myocardial infarction in patients with cardiac risk undergoing total knee arthroplasty. The primary outcome included perioperative levels of brain natriuretic peptide \& cardiac troponins. Secondary outcomes included postoperative operative pain assessment using visual analogue scale, total amount of analgesic consumption, patient satisfaction \& cardiovascular complications (myocardial infarction, arrhythmias , heart failure, hypotension, hypertension \& the need for inotropic agents).

Eligibility criteria: Inclusion Criteria:

* presence and/or risk for coronary artery disease (CAD) as well as planned lower extremity surgery was considered. Presence of CAD was ascertained by history of myocardial infarction and diagnosis of typical angina or atypical angina with a positive stress test \& ECG finding. Risk for CAD included age (\> 65 years old), hypertension, smoking habit, blood cholesterol (\>240 mg/dL), and diabetes.

Exclusion Criteria:

* 1) severe impairment of left ventricular function (ejection fraction \< 40 %). 2) renal failure requiring hemodialysis. 3) known allergies to the drugs used in the present study. 4) contraindications to regional blocks (localized infection, and use of an antiplatelet drug within 3 days before the surgery). 5) unusual blood coagulation tests.

Primary outcomes:
measure: brain natriuretic peptide
timeFrame: immediately preoperatively
measure: brain natriuretic peptide
timeFrame: after 48 hours post-operatively
Secondary outcomes:
measure: visual analogue scale
timeFrame: after 6 hour postoperatively
measure: amount of analgesic consumption
timeFrame: after 48 hour postoperatively
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University Faculty of Medicin
Study officials:
References: