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NCT Number: NCT05340946

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

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

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Alexandria University Faculty of Medicin

Alexandria, 21615, Egypt

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

General anaesthesia

Procedure

intraoperative general anaesthesia followed by postoperative IV patient analgesia

Other names: intravenous patient controlled analgesia

spinal anaesthesia

Procedure

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

Other names: ultrasound guided femoral never block

Primary outcomes

  1. brain natriuretic peptide

    Time frame: immediately preoperatively

    marker for myocardial infarction

  2. brain natriuretic peptide

    Time frame: after 48 hours post-operatively

    marker for myocardial infarction

Secondary outcomes

  1. visual analogue scale

    Time frame: after 6 hour postoperatively

    a score to evaluate postoperative pain intensity

  2. amount of analgesic consumption

    Time frame: after 48 hour postoperatively

    the total amount of analgesic consumed by each patient

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 22, 2022
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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