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Showing 1-20 of 35 trials
NCT07491120
Neurocognitive decline has long been suspected to be a potential long-term complication of coronary artery bypass grafting surgery (CABG), with reports of post-operative cognitive dysfunction by objective testing approaching 15-50% of patients in the year following surgery. To determine the true rate of long-term cognitive dysfunction following CABG compared to percutaneous coronary intervention (PCI or coronary stent placement), we propose a multi-center, two-group, non-randomized study using computer-based customized neurocognitive testing (Cogsate), prior to the procedure and then at 30 days, 1-year and 2-years after revascularization to evaluate cognitive function vital for the maintenance and advancement of professional and personal activities. It is anticipated that the study will document a higher rate of cognitive dysfunction in the CABG group, that the landmark study will provide both the patient and physician with the information necessary to make an informed decision regarding the cognitive risks of CABG versus PCI when faced with the need for coronary revascularization, and that these results will change the clinical practice of recommending CABG as a primary revascularization option for those wishing to preserve cognitive function.
NCT07451522
The goal of this clinical trial is to study postoperative analgesia in patients undergoing CABG. And learn if tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) treats pain not inferiory then morphine. The main questions it aims to answer are: Does tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) lower the VAS score same way as a morphine? What medical problems do participants have when taking tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid)? Participants will: Group (1)- subcutaneous single dose of morphine 10 mg would be administred based on VAS score \> 3 during 24 hours after CABG. Exprimental group (2)- subcutaneous single dose of tafalgin (tyrosyl-D-arginyl-phenylalanyl-glycine amid) - 0.4 mg would be administred based on VAS score \> 3 during 24 hours after CABG. Efficacy was assessed using the VAS scale decreassion. Hemodynamic parameters and arterial blood gases were also assessed.
NCT07120932
Objective: To determine the effect of Emotional Freedom Techniques (EFT) on pain, cardiac anxiety and sleep quality in patients undergoing Coronary Artery Bypass Graft (CABG) surgery. Materials and Methods: The study will be conducted between 2025 and 2026 as a pretest-posttest, parallel design (1:1) randomized controlled trial. The study population will consist of patients undergoing coronary artery bypass grafting (CABG) at the Kütahya City Hospital Cardiovascular Surgery Department. The sample size was determined to be 66 patients, with 33 patients each in the experimental and control groups. Measurement tools include a Personal Information Form, Visual Analog Scale (VAS), Cardiac Anxiety Scale, and Richard Campbell Sleep Scale. Data will be collected through one-on-one patient interviews. The researcher has successfully completed a 3.5-hour EFT training program at the Boğaziçi Education Institute. EFT will be administered to the patients by the researcher. Patients undergoing coronary artery bypass graft surgery at the Cardiovascular Surgery Clinic who volunteer to participate in the study and meet the inclusion criteria will complete the Informed Consent Form, Personal Information Form, Visual Analogue Scale (VAS), Cardiac Anxiety Scale, and Richard-Campbell Sleep Scale. Patients will then be assigned to the experimental or control groups by a person other than the researcher based on the randomization list. Patients in the experimental group will receive EFT in addition to standard cardiovascular surgery clinic procedures, while patients in the control group will receive standard cardiovascular surgery clinic procedures. Data analysis will be conducted using SPSS. The study will be conducted in accordance with the principles of the Declaration of Helsinki. Findings: The findings of the research will be written after the data to be obtained after the implementation of the research and data collection will be analyzed in the SPSS program. Conclusion: The results of the research will be written by determining the findings after analyzing the data to be obtained after the implementation of the research and data collection in the SPSS program.
NCT07386990
This study seek to compare two different solutions used to protect the heart during cardiac surgery. 40 adult patients planned for coronary artery bypass surgery with cardiopulmonary bypass machine assistance will be included in the study. Blood samples from the first 48 hours after surgery will be analyzed together with physical data, x-ray-results, ecg and general outcome after surgery.
NCT07207421
This randomized controlled trial aims to evaluate the impact of Ultra-Fast-Track (UFT) anesthesia on postoperative recovery in patients undergoing elective coronary artery bypass grafting (CABG). UFT anesthesia targets extubation in the operating room or within the first hour after surgery, whereas standard care involves transfer to the intensive care unit (ICU) with subsequent extubation according to routine protocols. A total of 100 patients will be randomized in a 1:1 ratio. The primary outcome is the maximum Vaso-Inotropic Score (VIS) within the first 24 postoperative hours. Secondary outcomes include postoperative pain scores (VAS), Quality of Recovery-15 (QoR-15) scores, opioid and analgesic requirements, ICU and hospital length of stay, time to mobilization, and postoperative complications. This study seeks to determine whether UFT anesthesia can safely reduce inotropic support requirements and enhance early recovery following CABG.
NCT07377149
This is a healthcare quality improvement study focused on increasing the utilization of arterial grafts in isolated coronary artery bypass grafting (CABG). Evidence indicates that arterial grafts, compared with venous grafts, provide superior long-term patency, which are recommended to use by the clinical practice guidelines. In hospitals where the use of the internal mammary artery as a graft is relatively low(\<90%) among CABG patients, multiple interventions will be implemented to improve its adoption rate. In hospitals where internal mammary artery graft utilization is already high(≥90%), various interventions will be introduced to promote the use of multiple arterial grafts (defined as the use of two or more arterial conduits). The study targets healthcare professionals as the primary subjects of intervention, with no direct interventions applied to patients during the study period. Changes in the internal mammary artery graft utilization rate and the multiple arterial graft utilization rate before and after the intervention will serve as the primary endpoints for evaluating intervention effectiveness in the two types of hospitals, respectively.
NCT07357675
EA-230 is a new therapy that may help people recover faster and have fewer problems after bypass surgery. In an earlier clinical trial, participants who received EA-230 during Coronary Artery Bypass surgery stayed in the Intensive Care Unit (ICU) and the hospital for a shorter time and had fewer serious complications, compared to those who received a placebo (an inactive therapy). The use of EA-230 was safe and well tolerated. This trial will test EA-230 in more participants to see if it really works and is safe to use in the future. This is a Phase III trial. It will take place in multiple locations and will follow a double-blind, randomized, placebo-controlled clinical design, meaning neither doctors nor participants will know whether they receive EA-230 or placebo during the trial. Assignment to EA-230 or placebo occurs by chance, like throwing dice. The total duration of the trial, including medical check-ups, will be approximately 71 days. There is a total of 10 visits, including a screening-, a pre-operative-, and 2 remote visits. 7 of these visits are during your stay at the hospital.
NCT07360327
The introduction of synthetic opioids in 1960 to general anesthesia together with sedative hypnotics and muscle relaxants allowed the appearance of the concept of multimodal balanced anesthesia. Although they help in achieving hemodynamic stability during anesthesia of open heart surgeries, their administration consequences are neither scarce nor benign to the patient. Perioperative opioids are associated with increased incidence of respiratory depression, prolonged mechanical ventilation, nausea and vomiting, prolonged sedation, Postoperative ileus (POI), urine retention, Postoperative cognitive dysfunction (POCD), immune depression and hyperalgesia (Beloeil et al., 2018). Coronary artery bypass graft surgery with cardiopulmonary bypass (CPB) is particularly vulnerable to the above-mentioned complications. Indeed, some of the side effects of this surgery overlap with the adverse effects of opioids. Postoperative pulmonary complications are observed in up to 50% of patients (Fisscher et al., 2022) and POCD or delirium in 4-54% according to studies (Bhushan et al., 2021). Whereas major gastrointestinal complications are estimated to occur in around 3% of patients, essentially acute pancreatitis, postoperative ileus (Marsoner et al., 2019). Opioid-free anesthesia (OFA) strategies have emerged to avoid intraoperative opioid use. It is based on the fact that a sympathetic reaction evidenced by hemodynamic changes in an anesthetised patient does not systematically reflect pain. In addition, a sleeping patient will not recall pain, while hormonal stress and sympathetic and inflammatory reactions can be controlled by therapeutic classes
NCT07331558
It will be a randomized clinical trial with a sample size of 66. A convenient sampling technique will be used to recruit the CABG phase II patients for the study. Then, they will be divided into three groups by block randomization. Weight-bearing Liuzijue Qigong will be given as a baseline treatment to all groups. In group A, patients will engage in multimodal circuit training while simultaneously viewing the nature scenes through VR in a clinical setting, in group B, patients will be given multimodal circuit training in a clinical setting while in group C, patients will be given multimodal circuit training through telerehabilitation. The dyspnea 12 Questionnaire will be used for measuring dyspnea, Cooper's 12-minute test will be used to assess cardiorespiratory fitness, echocardiography will be used to assess Left ventricular ejection fraction, EQ-5D-5L will be used to assess quality of life, and Pittsburgh Sleep Quality Index (PSQI) will be used to assess the quality of sleep. Data will be entered and analyzed through SPSS version 21.
NCT07060937
The purpose of this research is to determine which performance based functional outcome test among Time up and go test, Five times sit to stand test, 2 minute walk test and 6 minute walk test has the greatest significance in improving functional outcomes in post-CABG surgery patients.
NCT07263724
This methodological study aims to determine the level of agreement between nurses and an artificial intelligence system (ChatGPT-4.0) in providing scenario-based discharge education for patients who have undergone coronary artery bypass graft (CABG) surgery. Thirty standardized patient scenarios representing different demographic, clinical, and psychosocial characteristics will be used. For each scenario, both expert nurses and ChatGPT-4.0 will prepare discharge education content based on six main domains and twenty-four subtopics identified from the literature and clinical guidelines. The educational materials will be independently evaluated by two blinded reviewers in terms of content accuracy, completeness, scientific consistency, and clarity of language. Agreement between nurses and AI-generated content will be analyzed using Cohen's Kappa coefficient and Fisher's Exact Test. The findings are expected to provide evidence for the reliability and applicability of AI-assisted discharge education systems in cardiac surgery nursing practice.
NCT07249164
This observational study uses de-identified electronic health record data from the TriNetX Global Collaborative Network (2010-01-01 to 2025-07-01) to examine whether perioperative dexmedetomidine (DEX) is associated with 30-day outcomes after adult cardiac surgery. Adults aged 18-100 years undergoing first-time coronary artery bypass grafting or heart valve surgery are included. Exposure is any DEX administration from 24 hours before to 48 hours after the index operation; comparators receive no DEX in this window. The primary outcome is delirium within 30 days. Secondary outcomes are 30-day all-cause mortality, acute kidney injury, pneumonia, sepsis, red blood cell transfusion/major bleeding, myocardial infarction, ischemic stroke/transient ischemic attack, atrial fibrillation, mechanical ventilation \>96 hours (days 4-30), and 30-day readmission (days 1-30). No treatments are assigned by investigators and no identifiable information is used. Findings aim to inform perioperative sedation strategies in routine cardiac surgery care.
NCT06873620
This study aims to investigate the relationship between the ratio of cardiopulmonary bypass (CPB) time to cross-clamp (CC) time and postoperative complications in open heart surgery. While CPB time and CC duration have been linked to complications, no study has explored the specific ratio between CPB time and CC time in relation to postoperative outcomes. This prospective study seeks to fill that gap.
NCT07138534
The basic concept of prehabilitation is to increase the functional capacity of the individual to withstand an expected injury. It embodies the idea of being proactive against the common reactive approach of rehabilitation. While the initial prehabilitation model was limited to physical training, it has now evolved into a multimodal entity that includes nutritional optimisation, psychosocial preparation and smoking cessation in addition to exercise programmes. In the last decade, there has been an increasing effort to coincide prehabilitation with surgery, as surgery is rightly perceived as a stressor for human structural and physiological functions.
NCT06726239
This study is planned as a randomized controlled experimental study to determine the effect of progressive relaxation exercises applied before mobilization on pain, anxiety and physiological parameters in patients undergoing coronary artery bypass graft surgery.
NCT07031128
One of the most common major surgeries that older patients undergo is coronary artery bypass grafting surgery (CABG), which is performed in approximately 400,000 patients in the United States each year. CABG invokes a massive surgical stress response, with systemic epinephrine increasing 33-fold and norepinephrine increasing 3-fold. Initially, local tissue injury results in a sterile inflammation, releasing damage-associated molecular patterns (DAMPS). DAMPS activate neutrophils, bringing a cascade of cytokines, complement, and coagulation changes. Activation of nociceptors results in a neurometabolic response involving the sympathetic nervous system and hypothalamus-pituitary axis. This brings about systemic effects including changes in basal metabolic rate, hyperglycemia, lipolysis, negative nitrogen balance, and release of cytokines and complement. Although the surgical stress response is essential for wound healing and is usually self-limiting, an exaggerated response may occur resulting in multiple organ dysfunction. The acute phase of the surgical stress response is often followed by secondary insults that may be either sterile or pathogen-induced (such as postoperative infection).In the "two-hit" model of surgical stress response, there is an exaggerated response even to minor insults in vulnerable individuals who were primed by the initial stress response. Changes in the microbiome may also occur, developing a "pathobiome" that may enter the systemic circulation. If left unchecked, this second hit may result in the development of systemic inflammatory response syndrome (SIRS) and multi-organ failure. Chronological ageing changes the innate and adaptive immunity of patients. Biological hallmarks of aging such as genomic instability, mitochondrial damage, glycation of proteins, and cellular senescence all result in increased oxidative stress and systemic inflammation. Aging brings about a pro-inflammatory innate immune responsiveness that often occurs even in the absence of an inflammatory threat. This is termed inflammaging. Paradoxically, inflammaging is associated with an increased risk of infection and poor response to stressful events. At the same time, there is an age-associated loss of T-cell function, particularly in naïve CD8 T-cells. This deficit is termed immunosenescence and is characterised by reduced pathogen recognition, chemotaxis, and phagocytosis.
NCT06967779
This study is aimed at finding a correlation between postoperative delirium occurrence, severity and duration after cardiac surgery and the level of brain-derived neurotrophic factor (BDNF) in plasma as a marker of brain injury induced by cardio-pulmonary by-pass and its association with genetic predisposition in patients undergoing coronary artery bypass grafting (CABG) carrying BDNF gene polymorphism (Val66Met).
NCT06958913
It is important to establish a stable haemodynamics in patients undergoing cardiac surgery. Haemodynamic depression is common during induction of anaesthesia \[1\]. Sympathetic response due to tracheal intubation creates unwanted hypertensive responses on haemodynamics. Dexmedetomidine decreases stress responses and may provide a stable haemodynamics in situations such as surgery or induction of anaesthesia \[2-4\]. It may increase the tendency to hypotension and bradycardia by weakening the hyperdynamic response caused by sympathetic effect \[5,6\]. Concurrent use of dexmedetomidine may reduce anaesthetic opioid doses and provide more stable haemodynamics on systolic arterial pressure in patients undergoing CABG \[7\]. During cardiopulmonary bypass, dexmedetomidine may provide myocardial protection by exerting anti-inflammatory effects and may be beneficial for rapid recovery \[6,8,9\]. In cardiac surgery, dexmedetomidine provided bidirectional regulation of the anti-inflammatory response in which it showed antioxidant properties by inhibiting proinflammatory cytokine production and lipid peroxidation \[10,11\]. Dexmedetomidine in combination with propofol resulted in lower myocardial enzyme values than propofol alone \[12\]. The cardioprotective effects of propofol are dose-dependent; however, haemodynamic instability may be a concern at higher doses. In addition, dexmedetomidine may be considered a valid alternative to propofol, mainly because of its haemodynamic stability and possible myocardial protective effects \[13\]. It has been shown that dexmedetomidine pretreatment in valvular heart surgery can reduce the dose of propofol and the duration of mechanical ventilation and provide myocardial protection without an increase in adverse events \[14\]. Our study had two aims. The first was to provide a more stable haemodynamics by adding dexmedetomidine to induction in open cardiovascular surgery anaesthesia. Hypotension during induction and hypertensive response during tracheal intubation were tried to decrease. The second was to evaluate the effect of dexmedetomidine on cardiac enzymes only during induction, i.e. to evaluate its cardiac protective efficacy.
NCT06645327
To investigate the superior vena cava collapsibility index (SVC-CI), measured via transesophageal echocardiography (TEE), as a marker of fluid responsiveness. Two groups will be compared in this study. Groups will be identified by obtaining cardiac output (CO) by standard means using the TEE or pulmonary arterial catheter (PAC). Both of these monitors are considered standard for patient's undergoing coronary artery bypass grafting surgery (CABG) and recording initial CO readings. Based on CO, the patient's will be placed in study groups one or two. Participants with normal and mildly reduced left ventricular ejection fraction (LVEF \>40%) for group one and those with moderately to severely reduced LVEF (\<40%) in the second group. Following group separation, we will measure the SVC-CI and CO metric in both groups. The intervention will be an operating room table tilt test (head up and then head down) to artificially simulate giving the patient additional fluid. Before and after table tilt, the SVC-CI and CO will be obtained and measured. The SVC-CI is a mathematical equation determined by distance measurements taken via TEE to identify how much the superior vena cava has collapsed following table tilt. Participants will be considered responders if the CO increases by 12% following intervention. Non responders less than 12% change in CO following intervention. Our hypothesis is that the SVC-CI can differentiate responders vs non-responders with regards to fluid responsiveness with adequate sensitivity and specificity in participants with CAD undergoing isolated CABG. The SVC-CI numerical values for the two groups, responders and non-responders, will calculate a threshold of sensitivity and specificity percentages for future patients undergoing CABG.
NCT06777342
This is a multicenter, randomized, controlled clinical trial aimed to determine whether preoperative sleep interventions could reduce the incidence of adverse outcomes, such as postoperative delirium, in adult patients undergoing cardiac surgery. The study will include adult patients undergoing coronary artery bypass grafting and/or valve surgery with concomitant sleep disorders, as assessed by the Pittsburgh Sleep Quality Index. All participants will be randomly assigned to placebo, placebo + cognitive behavioral therapy, and melatonin + cognitive behavioral therapy in a 1:1:1 ratio. The primary outcome is the incidence of postoperative delirium within 7 days after surgery or before discharge, and secondary outcomes include postoperative cognitive function, sleep quality, and severity and duration of delirium. The results of this study will provide suggestions for the prevention of delirium after cardiac surgery.