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Showing 1-18 of 18 trials
NCT07533370
The goal of this clinical trial is to learn if an extended emergence from anesthesia can improve recovery room (Post-Anesthesia Care Unit or PACU) outcomes in lower-leg or foot surgery with nerve blocks. The primary questions it aims to answer are: * Does a longer wake-up help participants think more clearly soon after surgery compared with usual approaches? * Does it lower pain scores, lower the amount of pain medications used, and shorten the time it takes to go home from recovery room? Researchers will compare 2 groups of adults who are having similar lower-extremity orthopaedic surgeries with regional and propofol anesthesia.
NCT07411612
Postoperative delirium is a frequent and serious complication in older surgical patients, linked to prolonged hospitalization and long-term cognitive decline. The pathogenesis of delirium possibly includes inflammation and blood-brain barrier disruption. Early identification of at-risk patients is limited by the lack of reliable biomarkers. Therefore, we will evaluate as our primary aim the association between S100B measured within 2 hours after surgery and the occurrence of postoperative delirium within the first three postoperative days in patients over the age of 65 undergoing major non-cardiac, non-intracranial and non-vascular surgery. We will further evaluate the association between NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will also evaluate the predictive value of S100B, NSE, IL-6 and Copeptin concentrations, measured within 2 hours after surgery, on the occurrence of delirium within the first three postoperative days. We will measure S100B, NSE, IL-6, and Copeptin preoperatively, within two hours after surgery and daily for the first three postoperative days. Delirium will be assessed twice daily in the morning and evening for the first three postoperative days. In the course of this study we will establish a biobank of plasma and serum samples of patients, which are drawn preoperatively and within the first two hours after surgery.
NCT07350122
This study will test whether using a Bispectral Index (BIS) monitor to guide sedation can reduce the amount of sedative medication given to adults in the intensive care unit (ICU) after cardiac surgery. BIS is a non-invasive, EEG-based monitor that shows a number from 0-100 to reflect level of consciousness. Researchers will compare BIS-guided sedation to standard sedation guided by clinical scales (such as the Richmond Agitation-Sedation Scale, RASS). About 144 participants will be randomly assigned (1:1) to one of two groups at two hospitals in Austria (Medical University of Graz and Klinikum Wels-Grieskirchen). In the BIS group, clinicians will use BIS values and standard care to titrate sedation and will aim to avoid sustained BIS values below 50. In the control group, sedation will follow standard practices using clinical scales; BIS will be recorded but hidden from caregivers. The trial is open-label for treating staff; outcome assessors and data analysts will be blinded. Participants will be in the study during their ICU sedation and mechanical ventilation period (typically more than 6 hours), with follow-up through ICU and hospital discharge. The primary outcome is the time-averaged dose of propofol (mg/kg/h) given during continuous ICU sedation until weaning (up to 72 hours). Secondary outcomes include duration of ventilation and sedation, depth of sedation measures, sedative and catecholamine doses, pulmonary infections (including ventilator-associated pneumonia), ICU and hospital length of stay, delirium, and in-hospital mortality. Risks are minimal and may include mild skin irritation from forehead electrodes. Possible benefits include improved sedation management; benefits are not guaranteed. Taking part is voluntary.
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.
NCT07202208
The main objective of this research will be to investigate whether the control of care provided by the family/caregiver can prevent the onset of delirium in individuals undergoing surgical intervention for hip fracture. The research will be a randomized, single-blind, parallel, two-arm clinical trial that compares two conditions: intervention group, hereafter IG (Delirium Zero protocol based on a space-temporal orientation poster for the patient, a clock hung on the wall next to the orientation poster, and a checklist for the preventive measures taken by the caregiver/family), and control group, hereafter CG (standard of care). The participants will be patients over 65 years old, admitted to the trauma hospitalization units of the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain), operated on for hip fracture and accompanied by a relative/caregiver. The research will be carried out at the La Fe University and Polytechnic Hospital (La Fe Health Department, Valencia, Spain) because it is the reference hospital for the Valencian Community, and because the rooms in this center are private, which allows for no interference between the intervention under study (in GI) or the standard care (GC).
NCT07078578
This study aims to develop and prospectively validate a machine learning-based prediction model for postoperative delirium in kidney transplant recipients, using perioperative clinical data. Delirium is a common and serious postoperative complication that significantly increases morbidity, mortality, and healthcare costs. By analyzing electronic medical records from kidney transplant patients, including preoperative, intraoperative, and postoperative variables, the study seeks to identify high-risk patients and key predictors. Six machine learning models, including XGBoost, LGBM, GBC, LR, ANN, and SVM, will be constructed and evaluated, with a soft voting ensemble classifier used to optimize prediction performance. The goal is to improve early recognition and clinical management of postoperative delirium in kidney transplant patients.
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).
NCT06973967
The aim of this study is to investigate the relationship between low-flow and normal-flow anesthesia techniques and the development of postoperative delirium in elderly patients undergoing surgery for hip fracture.
NCT06958393
Background Postoperative delirium (POD) is a common acute and transient form of brain dysfunction in elderly patients following surgery that can lead to serious adverse clinical outcomes and even death. Although existing studies have preliminarily investigated the effects of opioid-free anaesthesia (OFA) on POD, high-quality evidence on these effects for elderly patients undergoing gastrointestinal surgery remains limited. This study aims to investigate the effects of OFA on the development of POD in elderly patients following gastrointestinal surgery. Methods and analysis: This single-centre, prospective, randomized controlled trial will be conducted at the First Affiliated Hospital of Shandong First Medical University, China. A total of 406 patients aged 65 years or older who are scheduled for elective gastrointestinal surgery will be randomly allocated to receive either opioid-free anaesthesia (OFA; dexmedetomidine, esmolol, and esketamine) or conventional opioid-based anaesthesia (OBA). The primary outcome is the incidence of POD 7 days after surgery. The secondary outcomes are all-cause mortality within 30 days after surgery, intraoperative haemodynamic changes, the 15-item quality of recovery (QoR-15) scores at 24 h, 48 h, and 72 h after surgery, complications during postoperative hospitalization, pain numerical rating scale (NRS) score at 72 h after surgery, incidence of nausea and vomiting at 72 h after surgery, morphine milligram equivalent for analgesics at 72 h after surgery, duration of anaesthesia (from induction to discontinuation), duration of surgery (from skin incision to the last suture), duration of post-anaesthesia care unit (PACU) stay, and length of hospital stay. Discussion: The results of this study may shed light on the effects of OFA on POD in elderly patients undergoing gastrointestinal surgery. The study is designed on the basis of the following key hypothesis: the use of opioid drugs for anaesthesia may increase the risk of POD through mechanisms such as blood-brain barrier destruction, neuroinflammatory responses, and central nervous system depression. Through the single-centre and prospective design of this randomized controlled trial, this study will directly analyse differences in the effects of OFA and conventional OBA on the incidence of POD, haemodynamic stability and long-term cognitive function in elderly patients. gastrointestinal surgery.
NCT06648681
Post-operative delirium is a common complication following cardiac surgery and is associated with increased 1 year mortality. Currently there are no drug therapies to prevent delirium. Orexin is a neuromodulator thought to play an important role in disordered sleep, one of the instigators of delirium. Lembrorexant is an orexin antagonist, originally approved for sleep, that may also reduce the incidence of delirium. The Investigators propose a pilot study to determine the feasibility of a randomized controlled trial comparing Lembrorexant to placebo in patients following cardiac surgery in reducing the incidence of delirium, and improving sleep.
NCT06678529
To evaluate the efficacy of transcranial direct current stimulation (tDCS) in reducing the incidence of postoperative delirium (POD) in elderly patients undergoing hip fracture surgery. This single-center, double-blind, randomized controlled trial will enroll participants aged 65 years and older, scheduled for elective hip surgery under spinal anesthesia. Participants will be randomly assigned to either the active-tDCS group or the sham-tDCS group. The active-tDCS group will receive two sessions: one pre-surgery and one post-surgery, with electrodes positioned over the left dorsolateral prefrontal cortex and the right supraorbital area. Each session includes 15-second ramp-up phase at the start, 20 minutes simulation with 2 mA current and 15-second ramp-down phase at the end. The sham-tDCS group will receive two sham procedures with no actual current delivered. Functional brain activity will be monitored before and after each session or sham procedure to assess changes in cortical activation and connectivity using functional near-infrared spectroscopy (fNIRS). The primary outcome measure will be the incidence of POD, assessed using the 3-Minute Diagnostic Interview for Confusion Assessment Method (3D-CAM). Secondary outcomes include the severity of delirium, postoperative pain, anxiety, depression, cognitive function, and sleep quality.
NCT06761092
Analyzing the effectiveness of nebulized dexmedetomidine 2 mcg/kg in reducing the incidence of post-anesthesia delirium in preschool children undergoing elective surgery with sevoflurane inhalation general anesthesia. Researchers will compare nebulized Dexmedetomidine to a placebo (a look-alike substance that contains no drug) to see if the drug can reduce post anesthesia delirium incidence.
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.
NCT06772129
The aim of this quasi-experimental study was to examine the effect of lavender aromatherapy on delirium in patients who underwent fracture surgery, were in intensive care, and were over 60 years old. The main question of the study was, does lavender aromatherapy affect delirium scale scores? In order to examine the effect of lavender oil on delirium, the researcher will provide routine care to one group and apply aromatherapy to the other group. Both groups will be evaluated by the researcher at eight-hour intervals with the Nu-DESC delirium screening scale and the results will be compared.
NCT06701643
Postoperative delirium is a frequent complication in children undergoing general anesthesia. It has been suggested that inflammation and oxidative stress contribute to the pathophysiology of delirium. The aim of this prospective observational study was to investigate the relationship between inflammatory markers, and delirium. The main questions it aimed to answer were: * Is there a realtionship between delirium and neutrophil-to-lymphocyte ratio? * Is there a realtionship between delirium and platelet volume? * Is there a realtionship between delirium and platelet distribution width? * What is the incidence of postoperative delirium in the study group?
NCT06686550
The investigators are going to conduct a prospective observational cohort study in pediatric patients aged 28 days to 14 years old scheduled for elective cardiac surgery with cardiopulmonary bypass. The primary purpose of this study is to explore the effect of preoperative sleep disturbance on the incidence of postoperative delirium. Sleep status will be assessed using the Brief Infant Sleep Questionnaire(BISQ) and Children's Sleep Habits Questionnaire (CSHQ), and postoperative delirium status will be evaluated by Cornell assessment of pediatric delirium(CAPD). During the peri-operative period, children will wear actigraphs to record their sleep parameters.
NCT06631534
The aim of this randomized trial is to determine efficacy of dexmedetomidine in improving quality of recovery in pediatric patients undergoing interventional catheter closure of ASD while maintaining the hemodynamic parameters. Additionally he stress reducing effects of dexmedetomidine will be investigated in this population . The main questions it aims to answer are: Does Dexmedetomidine maintain stable hemodynamics in pediatric patients undergoing transcatheter ASD Closure while improving their quality of recovery? Does dexmedetomidine prolong duration of recovery and time to extubation in pediatric patients ? Does dexmedetomidine exert stress reducing properties in this population? Participants will: Either be administered Dexmedetomidine in a loading/maintenance regimen or a placebo, with hemodynamics being monitored at the baseline, intraoperatively and postoperatively, with recovery time and quality of recovery especially emergence delirium being monitored. Stress hormone levels will be sampled at baseline and postoperatively.
NCT06597812
In this study, the cognitive status of the patients in the preoperative period was taken into consideration and the development of delirium after the surgery was investigated. There is no harm to the patient.