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

Myocardial Ischaemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05340946
• Other study ID #: 0305415
• Status: Completed
• Phase: N/A
• Start date: September 5, 2021
• Est. completion date: April 15, 2022

Study information

• Verified date: April 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: April 15, 2022
• Est. primary completion date: March 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ischemia
• Myocardial Ischaemia
• Myocardial Ischemia

Intervention

Procedure:
• general anaesthesia
intraoperative general anaesthesia followed by postoperative IV patient analgesia
• spinal anaesthesia
patient received spinal followed by continuous ultrasound guided femoral never block.

Locations

Country	Name	City	State
Egypt	Alexandria University Faculty of Medicin	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	brain natriuretic peptide	marker for myocardial infarction	immediately preoperatively
Primary	brain natriuretic peptide	marker for myocardial infarction	after 48 hours post-operatively
Secondary	visual analogue scale	a score to evaluate postoperative pain intensity	after 6 hour postoperatively
Secondary	amount of analgesic consumption	the total amount of analgesic consumed by each patient	after 48 hour postoperatively