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NCT06127901
To determine the overall prevalence of postoperative delirium (POI) and its association with different risk factors in order to establish prevention plans to reduce its incidence and/or duration in Spanish hospitals. To this end, patients over 18 years of age who underwent urgent and scheduled surgery requiring hospital admission under any type of anaesthesia during two specific days will be recruited and pre-, intra- and postoperative data will be collected.
NCT07276503
Basics (state of scientific knowledge): Delirium is an acute disturbance of consciousness and attention that develops over a short period of time and fluctuates in severity. It is accompanied by a deterioration in cognitive performance, such as memory deficits, disorientation, and speech and thinking disorders, which significantly exceed the degree of any pre-existing limitations . Surgery and intensive medical treatment are considered to be two of the triggers. In cardiac surgery, the incidence is reported to be between 10 and 50%, depending on the patient population. Delirium occurs approximately 3-4 days after surgery and lasts for several days. Relevant factors in the cardiac surgery population include age, duration of aortic clamping time or surgical technique, pre-existing conditions such as the extent of heart failure (EuroScore), diabetes mellitus, mental and cognitive impairments, or carotid stenosis. Both current studies and current recommendations emphasize prevention and the lack of successful treatment options. Preventive measures are primarily investigated in packages of measures. The study presented here aims to define risk populations and test the sensitivity and specificity of the MO-FA2-(TB) score for the development of delirium. Objectives of the study: Verification of the predictive score "MO-FA2-(TB)" for the development of postoperative delirium Recording of delirium and associated influencing factors and endpoints Categories examined in the score: Memory using a list of words that must be memorized and repeated after a few minutes Orientation by asking about the year, month, date, day of the week, city, and location Frailty using the ASA score Use of heart-lung machine Incision-suture time Study duration (for individual subjects): postoperative intensive care stay up to and including day 10 Study population Patients who have to undergo cardiac surgery with CPB Inclusion criteria: Elective cardiac surgery Heart valve surgery, bypass surgery with CPB Length of stay in ICU \> 48 hours Age ≥18 years Fluent German language skills Exclusion criteria: Age \<18 years Lack of capacity to give consent Emergency Readmission to intensive care unit OPCAB surgery, microsurgical procedure Recruitment: Information provided the day before surgery based on the surgical schedule If consent is given, score is recorded If ICU stay \>48 hours, treatment data is recorded, otherwise exclusion Data collection up to and including d10 Treatment data collected: Preoperative data, including ejection fraction, aids, abuse, scores collected ("4AT test" for rapid assessment of delirium and cognitive impairment, "MO-FA2-(TB)", "geriatric check" for identifying a geriatric patient) Intraoperative data, including duration of surgery, duration of heart-lung machine, acidosis Postoperative data in ICU, including delirium scores (ICDSC, CAM-ICU), days on ventilation, days of treatment, fluid intake, medication related to delirium, organ replacement therapy such as dialysis Number of cases: Approx. 100 patients Methodology Monocentric, observation
NCT07323485
Postoperative delirium may occur in children after general anesthesia, even following short procedures such as circumcision. Preoperative systemic inflammation has been associated with postoperative delirium in adults, but data in pediatric patients are limited. This prospective observational study aims to evaluate the association between preoperative inflammatory biomarkers and postoperative delirium in children aged 2-12 years undergoing elective circumcision under general anesthesia. Inflammatory biomarkers derived from routine complete blood count parameters, including NLR, PLR, MLR, SII, and SIRI, will be analyzed. Postoperative delirium will be assessed using the Pediatric Anesthesia Emergence Delirium (PAED) scale in the post-anesthesia care unit. The relationship between inflammatory biomarkers and delirium development and severity will be evaluated. This study seeks to identify simple preoperative markers that may help predict postoperative delirium risk in pediatric patients.
NCT07345403
The goal of this observational cohort study is to prove whether genetic, epigenetic, transcriptomic, proteomic, metabolomic, imaging, voice, and clinical markers can improve prediction of early complications after cardiac surgery in adult patients. The main questions it aims to answer are: Which biological and clinical markers are associated with: new-onset atrial fibrillation (NOAF), acute kidney injury (AKI), postoperative delirium (POD), vasoplegia, postoperative bleeding and 30-day mortality? Can combining these markers improve early prediction of postoperative complications compared with current clinical risk scores? Researchers will analyze a wide range of data collected before, during, and after cardiac surgery and compare patients who develop early complications with those who do not to identify risk factors and early biomarkers. Participants will: Provide biological samples (blood, urine, stool) before and after surgery for genetic, epigenetic, transcriptomic, proteomic, metabolomic, microbiome, and laboratory testing. Undergo standard preoperative and intraoperative imaging and clinical assessments. Allow collection of clinical data related to postoperative outcomes (For some participants) have voice and video recordings performed to help identify early signs of postoperative delirium. This study aims to improve early detection of postoperative complications and support development of personalized diagnostic and treatment strategies for patients undergoing cardiac surgery.
NCT07322744
Both frailty and a reduced preoperative lymphocyte-to-monocyte ratio (LMR) are known risk factors for postoperative delirium (POD). However, whether the relationship between LMR and POD varies by frailty status remains unclear. This study aimed to evaluate the frailty-stratified association between preoperative LMR and POD in older surgical patients.
NCT07277881
This clinical trial aims to establish whether reversing remimazolam sedation with flumazenil can prevent postoperative neurocognitive disorders in patients undergoing total hip replacement surgery. The main questions it aims to answer are: * Does administering flumazenil after surgery lead to an improvement in cognitive function (measured by the MoCA scale) at 24 hours post-operation compared to a placebo? * Does this intervention reduce the incidence of postoperative delirium within the first 48 hours? Researchers will compare flumazenil to a placebo (0.9% saline solution) to see if actively reversing sedation leads to better cognitive outcomes and a lower incidence of delirium. Participants will: * Undergo a planned total hip replacement surgery under spinal anesthesia. * Receive sedation with remimazolam during the operation. * At the end of the surgery, receive an intravenous injection of the study drug (flumazenil) or a placebo. * Undergo assessments for cognitive function (using the MoCA scale) and delirium (using the 4AT scale) before and at multiple time points after the surgery. * Complete a questionnaire about their quality of recovery (QoR-15).
NCT07297017
Naples Prognostic Score (NPS) originally developed to predict outcomes in inflammatory and malignant conditions; we asked if it can effectively predict postoperative delirium (POD) in elderly patients undergoing hip surgery? NPS integrate markers such as albumin, neutrophil-to-lymphocyte ratio, and lymphocyte-to-monocyte ratio-all of which have been linked to adverse postoperative outcomes including POD.
NCT07249047
Postoperative delirium is a sudden and reversible disturbance of mental function, occurring after surgery, characterized by confusion, inattention, and fluctuating mental status, which can manifest as agitation or lethargy. It is a common post-operative complication, especially in older adults, and is associated with longer hospital stays and worse recovery outcomes. Validated delirium screening tools such as the Intensive Care Delirium Screening Checklist (ICDSC) and the Richmond Agitation and Sedation Scale (RASS) are widely used tools to assess delirium. However, the sensitivity of these screening tools can be variable when used in real-world practice and may miss early cases of delirium. The optic nerve sheath is a protective sheath that encloses part of the optic nerve that is located at the back of the eye. Measurement of the optic nerve sheath diameter is usually done using ultrasound to detect increased cranial pressure. Previous studies that have been conducted have shown that increased ONSD may be associated with occurrence of postoperative delirium. The purpose of this study is to determine if there is an association between optic nerve sheath diameter (ONSD) and the occurrence of delirium after surgery. This study will be conducted at the London Health Sciences Centre and will include 300 patients.
NCT06869876
ORTOPOD PILOT STUDY is a non-randomized, non-interventional clinical study that addresses the issue of perioperative neurocognitive disorder (deterioration of cognitive functions in the preoperative and perioperative period) and its impact on the occurrence of postoperative delirium. Respondents meeting the entry criteria will undergo elective orthopaedic surgery (total hip arthroplasty) under general or regional anaesthesia.
NCT07108764
This study aims to compare the effect of intraoperative infusion of either lidocaine or dexmedetomidine on the incidence of postoperative delirium (POD) in elderly patients undergoing major surgeries. It also aims to evaluate the impact of both medications on intraoperative regional cerebral oxygen saturation (rSO₂).
NCT07101393
This study aims to investigate the incidence of postoperative stroke and neurocognitive impairment in patients undergoing coronary artery bypass grafting (CABG), with or without the use of epi-aortic ultrasound (EAU). Atherosclerosis in the ascending aorta is a known risk factor for perioperative stroke and systemic embolization. The identification of atherosclerotic plaques before manipulation of the ascending aorta is important in minimizing embolic complications. Neurocognitive function will be assessed using the standardized Mini-Mental State Examination (SMMSE) before surgery and within 7 days postoperatively or at discharge. This prospective, observational, case-control study will evaluate the relationship between the presence of atherosclerotic plaques detected by EAU and neurocognitive and neurologic outcomes following CABG surgery.
NCT07100197
Postoperative delirium is common in elderly surgical patients and is associated with complications and prolonged hospitalisation. The aim of the RECOVER study is to assess the efficacy of electroencephalo graph (EEG)-transcranial magnetic stimulation (TMS) treatment for the management of postoperative delirium.
NCT03629262
Delirium is common in the elderly after orthopedic surgery and is associated with worse outcomes. The investigators hypothesize that, for elderly patients after orthopedic surgery, dexmedetomidine supplemented intravenous analgesia can reduce the incidence of delirium and improve the long-term outcomes.
NCT03739476
Double blinded Clinical trial to test efficacy of Quetiapine versus placebo in reducing postoperative delirium in high risk surgical patients after three days of treatment.
NCT04529265
Postoperative Neurocognitive Disorders are the most common neurological complications after major surgery, which are associated with higher increased mortality and morbidity in elderly patients undergoing major surgery. Until now highly effective intervention has not been established yet. Recent preclinical studies suggest neuroinflammation may be linked to pathogensis of (postoperative delirium) POD and postoperative cognitive dysfunction (POCD). As Methylene blue(MB) has neuroprotective and anti-inflammatory properties, and it is a safe drug with long history of clinical use, we propose that inflammation-targeted interventions may be useful to prevent POD/POCD in surgical patients.
NCT05990790
Patients over the age of 65 years are at increased risk for developing delirium after noncardiac surgeries, resulting in increased morbidity and mortality. The prevention of postoperative delirium has been classified as a public health priority. However, so far data regarding possible intraoperative interventions to reduce the incidence of postoperative delirium is very scarce. Due to the more rapid wash-in and wash-out times of desflurane as compared to sevoflurane or propofol it seems reasonable that desflurane might be beneficial for the prevention of postoperative delirium. Therefore, we evaluate the effect of maintenance of anesthesia using desflurane, sevoflurane or propofol on postoperative delirium in elderly patients undergoing moderate- to high-risk major noncardiac surgery.
NCT06768580
The aim of this study is to assess the effect of oral melatonin versus intraoperative lidocaine infusion on incidence of postoperative delirium in elderly patients undergoing total hip arthroplasty under spinal anesthesia.
NCT06323616
Some changes in the patient's cognitive state are observed during the recovery period from general anesthesia. This period of behavioral dysregulation has been called emergence agitation (EA) and emergence delirium (ED). ED and EA occur in the early postoperative period (often within the first 30 minutes). The incidence of ED ranges from 10% to 80% in children and is described as a distressing clinical condition by 42% of pediatric anesthesiologists. Self-harm by the child increases the risk of delayed discharge and may increase the cost of medical care. Sevoflurane is a widely used agent for the induction and maintenance of anesthesia, but its use is associated with the occurrence of ED in the pediatric population. Clinical findings are characterized by hallucinations, struggling, restlessness, crying, and disorientation. In the literature, the Pediatric Anesthesia Rescue Delirium (PAED) Scale Score is used in the diagnosis of ED and EA. This score consists of 5 criteria (maximum score 20) scored using 0-4 point scales. These criteria; The child needs to make eye contact with the caregiver, the child's movements are purposeful, the child is aware of the environment, the child is restless/angry, the child cannot be consoled. While the sensitivity of ≥10 points for the diagnosis of ED is 64% and the specificity is 86%, the sensitivity of \>12 points for the diagnosis of ED is 100% and the specificity is 94.5%. Monitoring intraoperative depth of anesthesia in the adult population has been recommended by the American Society of Anesthesiologists (ASA) due to its potential benefits such as faster recovery time and lower drug dosage, as well as prevention of adverse effects such as the incidence of hypotension. The use of anesthesia depth monitors used so far for children is controversial because brain development in children has not yet been completed and the calculation algorithms of these indices are based on adult EEG characteristics. There are very few studies in the literature on the relationship between anesthesia depth monitoring and EA/ED in children, and further studies are needed.
NCT06466096
This is a prospective cohort study to explore the differences of serum indicators between elderly gastrointestinal neoplasms patients with postoperative delirium (POD) who either develop or do not develop long-term postoperative neurocognitive disorders (pNCD).
NCT06752421
This study aims to evaluate the effect of low tidal volume (LTV) ventilation during cardiopulmonary bypass (CPB) on postoperative delirium. It is hypothesized that the risk of delirium, which negatively impacts recovery following cardiac surgeries, can be reduced by improving cerebral perfusion and oxygenation through LTV. The study is designed as a prospective, randomized, controlled trial comparing delirium incidence, ICU stay duration, and 30-day mortality/morbidity rates between LTV and apnea groups. Primary outcomes will be assessed using the 3D-CAM method, while secondary outcomes include ICU stay duration and mortality/morbidity rates.