Comparison of the Effect of Two Anaesthesia Methods in Preventing Perioperative Myocardial Infarcation in Patients With Cardiac Risk Undergoing Total Knee Arthroplasty
Primary Purpose
Myocardial Ischaemia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
general anaesthesia
spinal anaesthesia
Sponsored by
About this trial
This is an interventional prevention trial for Myocardial Ischaemia
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.
Sites / Locations
- Alexandria University Faculty of Medicin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Group (G)
Group (F)
Arm Description
received general anaesthesia followed by IV patient-controlled analgesia (IV PCA).
received spinal anaesthesia followed by continuous ultrasound guided femoral never block once the anaesthesia-induced motor block resolved.
Outcomes
Primary Outcome Measures
brain natriuretic peptide
marker for myocardial infarction
brain natriuretic peptide
marker for myocardial infarction
Secondary Outcome Measures
visual analogue scale
a score to evaluate postoperative pain intensity
amount of analgesic consumption
the total amount of analgesic consumed by each patient
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05340946
Brief Title
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
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 5, 2021 (Actual)
Primary Completion Date
March 5, 2022 (Actual)
Study Completion Date
April 15, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Ischaemia
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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 ).
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group (G)
Arm Type
Experimental
Arm Description
received general anaesthesia followed by IV patient-controlled analgesia (IV PCA).
Arm Title
Group (F)
Arm Type
Experimental
Arm Description
received spinal anaesthesia followed by continuous ultrasound guided femoral never block once the anaesthesia-induced motor block resolved.
Intervention Type
Procedure
Intervention Name(s)
general anaesthesia
Other Intervention Name(s)
intravenous patient controlled analgesia
Intervention Description
intraoperative general anaesthesia followed by postoperative IV patient analgesia
Intervention Type
Procedure
Intervention Name(s)
spinal anaesthesia
Other Intervention Name(s)
ultrasound guided femoral never block
Intervention Description
patient received spinal followed by continuous ultrasound guided femoral never block.
Primary Outcome Measure Information:
Title
brain natriuretic peptide
Description
marker for myocardial infarction
Time Frame
immediately preoperatively
Title
brain natriuretic peptide
Description
marker for myocardial infarction
Time Frame
after 48 hours post-operatively
Secondary Outcome Measure Information:
Title
visual analogue scale
Description
a score to evaluate postoperative pain intensity
Time Frame
after 6 hour postoperatively
Title
amount of analgesic consumption
Description
the total amount of analgesic consumed by each patient
Time Frame
after 48 hour postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Alexandria University Faculty of Medicin
City
Alexandria
ZIP/Postal Code
21615
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Comparison of the Effect of Two Anaesthesia Methods in Preventing Perioperative Myocardial Infarcation in Patients With Cardiac Risk Undergoing Total Knee Arthroplasty
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