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NCT03839784
The research team is creating a foundational infrastructure in order to develop a precision medicine approach for geriatric patients who require surgery with anesthesia. The team plans to build the first of its kind comprehensive database of demographic and risk factor questionnaire responses, biobanked blood specimens, intraoperative electroencephalography (EEG), and inclusive cognitive testing throughout patient interaction starting at the preop appointment until a year later. This will be used to create a predictive model of periooperative neurocognitive disorders.
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.
NCT06161662
Transcutaneous electrical acupoint stimulation (TEAS) was reported to benefit the patients undergoing surgeries by reducing anesthetics consumption and decreasing anesthesia related adverse effects. Electroencephalogram (EEG) and EEG-related indicators are important indicators reflecting the conscious state of the brain, and different anesthetic drugs and anesthesia depths cause different EEG characteristic changes. The mechanism by which TEAS improves postoperative delirium (POD) is not clear, and whether changes in EEG characteristic parameters is involved needs to be further explored. Therefore, this study aims to observe the effect of TEAS at Neiguan and Shenmen acupoint on POD in elderly patients undergoing abdominal surgery, and to explore the EEG related mechanism underlying TEAS improving POD.
NCT06434948
The purpose of this study is to determine whether giving omega-3 fatty acids prior to and after cardiac bypass surgeries decreases the incidence of postoperative delirium in patients aged 65 and over.
NCT07445009
Hip replacement surgery (partial or total hip arthroplasty) is commonly performed in elderly patients and is associated with significant postoperative pain. Effective pain management is critical to support early mobilization, reduce complications, shorten hospital stay, and prevent postoperative delirium.This observational study evaluates the effect of two ultrasound-guided regional analgesia approaches on postoperative pain and recovery quality in patients aged 65 years and older undergoing hip arthroplasty under general anesthesia: Group 1: Pericapsular Nerve Group (PENG) block + Lateral Femoral Cutaneous Nerve (LFCN) block Group 2: PENG block + Lumbar Erector Spinae Plane (ESP) block Both techniques are applied as part of routine clinical practice at our institution. The primary outcome is quality of recovery assessed by the QoR-15 questionnaire at 24 hours after surgery. Secondary outcomes include postoperative opioid consumption, pain scores (NRS), incidence of postoperative delirium (NU-DESC), nausea and vomiting, and time to mobilization. Patients are also followed up by telephone at postoperative day 7 and day 30 for mortality and morbidity assessment.
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.
NCT05036538
Patients undergoing cardiac surgery often complain of anxiety before a major operation and the resulting stress. This circumstance is a risk factor for mental problems that may occur after the operation (e.g., delirium or memory deficits). This study aims to prevent these discomforts by a preoperative relaxation intervention.
NCT05595954
This international, multicentre prospective cohort study will assess whether perioperative duration and magnitude of mean arterial pressure (MAP) outside of an individual's cerebral autoregulation (CA) limits using near-infrared spectroscopy (NIRS) and transcranial Doppler (TCD) are associated with adverse neurological events. It is to investigate whether patients with a higher burden of cerebral haemodynamic insults have an increased incidence or poorer neurological outcomes. Associations between neurologic outcomes, neurobiomarkers and genetic tests will be explored.
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.
NCT06394778
Objective: To construct a perioperative EEG database for elderly patients under general anesthesia and to explore the relationship between their EEG spectrum characteristics and the occurrence and severity of postoperative delirium. Content: This study aims to investigate elderly patients undergoing elective orthopedic surgery under general anesthesia with endotracheal intubation, analyze the changes in the perioperative EEG spectrum and its correlation with the occurrence of postoperative delirium, and explore the relationship between perioperative EEG changes and the occurrence of postoperative delirium. Methods: Patients aged 60 years or older who were scheduled to undergo orthopedic joint replacement or spinal surgery and had a hospital stay of more than 2 days were selected. All patients underwent MMSE and 3D-CAM assessment before surgery. Before anesthesia induction, anesthesia depth monitoring electrodes were placed on the patient\'s occipital or frontal temporal region, and EEGs were collected in awake and quiet states, under general anesthesia, and during anesthesia recovery. In the PACU, the score was calculated based on the CAM-ICU scale. The patients were assessed with the 3D-CAM scale for awakening once a day at 15:00-20:00 the day before surgery, and twice a day at 9:00-11:00 and 15:00-20:00 during 1-5 days after surgery, or at any time when obvious delirium symptoms appeared, unless discharged from the hospital or taking sedatives (RASS\<-3). Ten minutes after the assessment, the occipital EEG was monitored when the patient was conscious and quiet, or when obvious delirium appeared. According to the test results of the 3D-CAM scale, it was determined whether the patient had postoperative delirium, and the patients were divided into the delirium group and the non-delirium group. The EEG characteristics of the two groups of patients were analyzed before, during, and after surgery. Research significance: The results of this study can provide objective indicators and theoretical basis for monitoring and diagnosing the occurrence and development of POD, which can help clinicians to identify patients with increased risk of delirium at an early stage, adjust the plan in time, and change the triggering risk factors of POD.
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.
NCT04443517
The investigators intend to recruit 600 participants to see if alpha power during anesthesia is influenced by analgesic medication and associated with a reduction of delirium following surgery.
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.
NCT07285187
Postoperative delirium (POD) is an acute brain dysfunction characterized by inattention, impaired consciousness, and cognitive and orientation disturbances, and is a common complication after cardiac surgery. The high incidence of up to 52% of POD in cardiac surgery patients lead to a range of adverse clinical outcomes.The brain tissue is enclosed in a rigid anatomical structure; when there is an obstruction to venous return from the brain, intracranial pressure can increase, and blood supply to the brain tissue can decrease, leading to central nervous system dysfunction. Systemic venous congestion can occur when there is right heart dysfunction or excessive volume load. When right heart failure and/or volume overload occurs, changes in right atrial pressure are transmitted to the venous system of organs throughout the body, with dilatation of the inferior vena cava (IVC), obstruction of blood return from the hepatic, portal, and renal veins, and abnormal venous flow signals and altered ultrasound Doppler flow patterns. The primary objective of this prospective cohort study is to explore if intraoperative systemic venous congestion is associated with POD after cardiac surgery. This study will also investigate the relationship between intraoperative systemic venous congestion and postoperative complications, and the relationship between each separate venous congestion and POD after cardiac surgery.
NCT07271394
Glucocorticoids can be used to inhibit postoperative systemic inflammatory response syndrome. They may reduce the risk of major complications and mortality. Previous studies on the effect of glucocorticoids on postoperative cognitive dysfunction may lack generalizability due to short follow-up periods for cognitive function after surgery, insufficient follow-up results of cognitive function throughout the entire hospitalization, and a single surgical approach. Clinical evidence provided by previous randomized controlled trials may be biased due to loss-to-follow-up rates caused by researchers' failure to timely follow up on cognitive dysfunction outcomes. Most previous randomized controlled trials investigating the effect of glucocorticoids on postoperative delirium have limitations, mainly including small sample sizes and limited statistical power. Given the high cost of conducting large-scale randomized controlled trials involving various types of perioperative abdominal surgeries in elderly patients and the practical difficulty of reducing loss-to-follow-up rates, there is an urgent need to find alternative approaches. In this study, we extracted data from the in-hospital electronic medical record system and conducted a target simulation trial based on the designed randomized controlled trial protocol investigating the effect of methylprednisolone sodium succinate on postoperative delirium in elderly patients undergoing abdominal surgery. Using existing data, we analyzed whether administration of methylprednisolone sodium succinate during anesthesia induction has an impact on the incidence of postoperative delirium in elderly patients undergoing abdominal surgery.
NCT07259850
Postoperative delirium (POD) is a frequent complication in older surgical patients and is associated with adverse outcomes, while frailty is also highly prevalent during the perioperative period. This study aimed to determine whether POD accelerates perioperative frailty worsening and to assess the effect of their coexistence on 1-year mortality.
NCT07239648
Establish a follow-up database for postoperative delirium in cardiac surgery patients, adopt a bidirectional cohort design to simultaneously analyze the associations between "preoperative exposure factors and postoperative delirium incidence" and "postoperative delirium and long-term adverse outcomes", and clarify the predictive factors and prognostic impacts of postoperative delirium.