Evaluation of Perioperative Myocardial Injury in Patients Undergoing Below-Knee Lower Extremity Surgery
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorAnkara City Hospital Bilkent
About this trial
The aim of this observational study was to detect myocardial damage by monitoring high-sensitive troponin I levels in patients undergoing below-knee extremity surgery with peripheral nerve block.
The primary question it aims to answer is:
How effective are peroperative high-sensitive troponin I levels in predicting myocardial damage?
High-sensitive troponin I levels will be monitored intraoperatively and at 24 and 48 hours postoperatively.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Patients over 18 years of age
Patients undergoing below-knee lower extremity surgery
Patients with ASA classifications I, II, III, and IV
Patients who have consented before the procedure
Disqualifiers
Patients in whom regional anesthesia is contraindicated
Patients who refuse to participate in the study
Trial population
Patients undergoing below-knee lower extremity surgery under peripheral nerve blockade
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
high sensitive Troponin I
Diagnostic testHigh sensitive Troponin I used to predict myocardial damage
Treatment groups
54 Participants
are divided into 1 treatment groupGroup A: All patients undergoing elective below-knee lower extremity surgery1 intervention
Trial outcomes
Primary outcomes
1
High sensitive Troponin I
peroperative High sensitive Troponin I
Time frame
01.09.2025-10.01.20262
High sensitive Troponin I
postoperative 24th hour High sensitive Troponin I
Time frame
01.09.2025-11.01.20263
High sensitive Troponin I
postoperative 48th hour High sensitive Troponin I
Time frame
01.09.2025-12.01.2026Secondary outcomes
1
hemodynamic parameters 1
intraoperative blood pressure (mmHg)
Time frame
01.09.2025-10.01.20262
hemodynamic parameters 2
intraoperative oxygen saturation (%)
Time frame
01.09.2025-10.01.20263
hemodynamic parameters 3
heart rate (/min)
Time frame
01.09.2025-10.01.2026Other outcomes
1
unexpected events
Sudden myocardial infarction occurring during the operation or within 1 month after the operation
Time frame
01.09.2025-10.02.20262
unexpected events
Cerebrovascular accident occurring during the operation or within 1 month after the operation
Time frame
01.09.2025-11.02.20263
unexpected events
rehospitalization during the operation and within 1 month after the operation
Time frame
01.09.2025-12.02.20264
unexpected events
Death during surgery or within 1 month after surgery
Time frame
01.09.2025-13.02.2026Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov