Clinical trials

The aim of this study is to determine the impact of ultrasound-guided bilateral intermediate cervical plexus block on the surgical stress response in patients undergoing total thyroidectomy, as measured by the concentration of stress and inflammatory biomarkers in the participants' saliva and serum. The study will be conducted on 48 subjects divided into two groups of 24: a control group receiving total intravenous anesthesia (TIVA) and an experimental group receiving TIVA combined with a bilateral intermediate cervical plexus block. Investigators hypothesized that a combination of bilateral intermediate cervical plexus block and total intravenous anesthesia (TIVA) would reduce the surgical stress response, as measured by salivary and blood biomarkers, compared to TIVA alone in patients undergoing total thyroidectomy. Should the research confirm the hypothesis, it will provide an objective scientific argument for including the block in standard anesthetic protocols for total thyroidectomy surgeries, with the ultimate goal of reducing the surgical stress response and ensuring faster patient recovery.

This randomized, open-label, single-centre controlled study evaluates the efficacy and safety of combined paracetamol and ibuprofen therapy with versus without famotidine in the treatment of calcific tendinitis of the shoulder. Outcomes include pain reduction, functional improvement, radiological changes, and need for additional interventions over a 12-month follow-up period.

A randomized, double-blind, prospective single-center clinical trial evaluating the effect of biological augmentation in anterior cruciate ligament (ACL) reconstruction. The study compares standard all-inside semitendinosus ACL reconstruction versus biologically enhanced reconstruction incorporating muscle tissue preservation and autologous bone and fibrin augmentation. The primary aim is to assess whether biological augmentation improves graft healing, integration, and clinical outcomes.

Aim: Comparison of tendon to bone ingrowth in bone tunnels and intra-articular remodeling of the graft after anterior cruciate ligament surgery with a muscle-tendon graft and those with a tendon graft. Subjects and methods: It is a single-blind prospective randomized study that would include at least 40 patients with an anterior cruciate ligament rupture. Patients would be randomly divided into two groups of minimally 20 patients each. Patients in the first study group would undergo ACL reconstruction with a muscle-tendon graft, while patients in the control group would be treated with the standard method of ACL reconstruction with a tendon graft. Expected contribution to the field: The assumption is that the obtained results could enable a better understanding of the contribution of remaining muscle fibers on the tendon in anterior cruciate ligament reconstruction operations to the tendon to bone ingrowth and intra-articular remodeling of the graft of operated patients.

This study evaluates whether re-sterilized (reprocessed) ablation catheters are as effective and safe as new ablation catheters when used for pulmonary vein isolation in patients with atrial fibrillation. Adult patients scheduled for catheter ablation will be randomly assigned to undergo the procedure using either a new catheter or a re-sterilized catheter, with identical procedural techniques applied in both groups. The study will compare procedural efficiency, safety, costs, and environmental impact between the two approaches. The results may support more sustainable and cost-effective use of medical devices in cardiac electrophysiology.

This study will include patients aged 50 and older scheduled for elective abdominal oncologic surgery, classified as ASA II and III due to increased anaesthetic and surgical risk. Gender will not be a stratification factor. Exclusion criteria include patient refusal, memory impairment, psychosis, known or suspected EEG abnormalities, chronic psychoactive medication use, urgent procedures, BMI below 18 kg/m² or above 35 kg/m², persistent arrhythmias, NYHA class III-IV heart failure, valvular disease, liver diseases, and anticipated surgery duration over six hours. Eligible patients must sign an informed consent form one day prior to surgery. Demographic data collected will include age, sex, operation type, comorbidities, ASA status, height, weight, and BMI. Randomisation will occur before the study begins with a sample size of 100 subjects based on a pilot study of 5 patients per group. Premedication and Monitoring: Patients will receive premedication per institutional protocol, which includes intramuscular midazolam. Intraoperative monitoring follows randomisation allocation. The control group will have standard measurements, including invasive pressure and ECG. Data collection will be handled by designated team members who will archive anaesthesia charts. After intubation, patients will be ventilated with 6-8 ml/kg of predicted body weight and a fresh gas flow of 1 L/min. Intervention Group Protocol: In the intervention group, monitoring will be established via radial artery cannulation under local anaesthesia, using LiDCOrapid®, Rainbow®, and Hb attachments. Baseline MAP and CO values will be recorded, with DO2 calculated automatically. Sensors will be positioned to monitor anaesthetic depth and rSO2 before pre-oxygenation. A noradrenaline infusion will maintain venous tone. Anaesthesia will use TCI with propofol and sufentanil, targeting specific values based on age groups. The primary goal is to maintain an rSO2 of at least 85% of baseline. If rSO2 falls below this threshold, a DO2 optimisation protocol will be initiated, adjusting conditions and administering fluids and medications as necessary. Control Group Protocol: In the control group, propofol and sufentanil will be administered as previously outlined with adjustments based on intraoperative responses and awareness. Rocuronium bromide will be used for neuromuscular blockade, with monitoring and administration of fluids managed by the attending anaesthesiologist. Data Recording: All data during procedures will be recorded digitally or manually, and post-procedure data will be downloaded for analysis. Patients will be transferred to the ICU for postoperative monitoring. Laboratory Analysis: Blood samples for routine analysis will be collected at three time points: prior to surgery, upon ICU admission, and 24 hours after. Parameters assessed include complete blood count, electrolyte levels, PT, aPTT, fibrinogen, blood gas parameters, lactate, troponin I, and NTproBNP. Outcome Measurements: Both groups will be monitored for duration of anaesthesia, drug administration, fluid volume, postoperative complications, mortality rates, and ICU length of stay (LOS). Continuous variables will be reported using descriptive statistics or interquartile ranges, while categorical variables will be shown as counts and percentages. Statistical analysis will be performed using Mann Whitney U test for continuous variables, repeated measures ANOVA for group comparisons, and chi-squared tests for categorical variables. ANCOVA will be employed to compare clinical outcomes with age as a covariate. The software package jamovi v2.5.3 will be utilized for statistical analysis with a significance level set at p \< 0.05.

Cardiology Research Dubrava registry is a prospective, single centre registry including patients with acute coronary syndrome with and without ST segment elevation, patients with heart failure who were prescribed with SGLT-2 inhibitors, patients implanted with TAVI, patients with venous thromboembolism, patients with pulmonary embolism who underwent thromboaspiration procedure, patients implanted with ICD, CRT and conduction system pacing devices, as well as patients with atrial fibrillation who underwent pulmonary vein isolation and are prescribed with long-term anticoagulation therapy.