Comparison of the Effect of Two Anaesthesia Methods in Preventing Perioperative Myocardial Infarcation in Patients With Cardiac Risk Undergoing Total Knee Arthroplasty

NCT ID: NCT05340946

Last Updated: 2022-04-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-05
• Study Completion Date: 2022-04-15

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).

Conditions

Myocardial Ischaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group (G)

received general anaesthesia followed by IV patient-controlled analgesia (IV PCA).

Group Type: EXPERIMENTAL

general anaesthesia

Intervention Type: PROCEDURE

intraoperative general anaesthesia followed by postoperative IV patient analgesia

Group (F)

received spinal anaesthesia followed by continuous ultrasound guided femoral never block once the anaesthesia-induced motor block resolved.

Group Type: EXPERIMENTAL

spinal anaesthesia

Intervention Type: PROCEDURE

patient received spinal followed by continuous ultrasound guided femoral never block.

Interventions

general anaesthesia

intraoperative general anaesthesia followed by postoperative IV patient analgesia

Intervention Type: PROCEDURE

spinal anaesthesia

patient received spinal followed by continuous ultrasound guided femoral never block.

Intervention Type: PROCEDURE

Other Intervention Names

intravenous patient controlled analgesia; ultrasound guided femoral never block

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Alexandria University Faculty of Medicin

Alexandria, , Egypt

Countries

Egypt

Other Identifiers

0305415

Identifier Type: -

Identifier Source: org_study_id