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

NCT05340946 | Completed

• 1 other identifier: 0305415
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Myocardial Ischaemia

Outcome Measures

Primary Outcomes (2)

• brain natriuretic peptide

  marker for myocardial infarction

  immediately preoperatively

• brain natriuretic peptide

  marker for myocardial infarction

  after 48 hours post-operatively

Secondary Outcomes (2)

• visual analogue scale

  after 6 hour postoperatively

• amount of analgesic consumption

  after 48 hour postoperatively

Study Arms (2)

Group (G)

EXPERIMENTAL

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

Procedure: general anaesthesia

Group (F)

EXPERIMENTAL

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

Procedure: spinal anaesthesia

Interventions

general anaesthesia PROCEDURE

intraoperative general anaesthesia followed by postoperative IV patient analgesia

Also known as: intravenous patient controlled analgesia

Group (G)

spinal anaesthesia PROCEDURE

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

Also known as: ultrasound guided femoral never block

Group (F)

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicin

Alexandria, 21615, Egypt

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Anesthesia, General; Analgesia, Patient-Controlled; Anesthesia, Spinal

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia; Anesthesia and Analgesia; Analgesia; Anesthesia, Conduction

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 ).

Study Record Dates

• First Submitted: April 17, 2022
• First Posted: April 22, 2022
• Study Start: September 5, 2021
• Primary Completion: March 5, 2022
• Study Completion: April 15, 2022
• Last Updated: April 22, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)