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Delirium clinical trials

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NCT ID: NCT05883280 Not yet recruiting - Emergence Delirium Clinical Trials

The Effect of Binaural Sound on the Occurrence of Emergence Delirium in Children Undergoing Strabismus Surgery

Start date: May 20, 2023
Phase: N/A
Study type: Interventional

The hypothesis of this study is that providing continuous binaural beats with a phase difference in alpha frequency during anesthesia can reduce the incidence of emergence agitation in pediatric patients. To test this hypothesis, the occurrence of emergence agitation will be compared between the group that received binaural beats and the group that did not receive binaural beats.

NCT ID: NCT05877326 Not yet recruiting - Clinical trials for Post-operative Delirium

Anaesthetic Depth and Short Term Delirium Post Cardiac Surgery Intervention

BISCAR
Start date: September 2023
Phase: N/A
Study type: Interventional

Postoperative delirium (POD) is a critical complication of major surgery and affects up to 70% of surgical patients over the age of 60 years. The additional healthcare costs associated with delirium exceed €50,000 per patient per year due to prolonged hospital stay, increased risk of long-term care or institutionalization, and the risk of developing dementia or cognitive impairment . Therefore, prevention of POD is a major goal in the perioperative setting. The investigator proposes this randomized study to evaluate the interest of a reduced anesthetic depth to prevent short-term cognitive disorders after cardiac surgery in elderly subjects. Method: Patients over 75 years old scheduled to undergo one of the cardiac surgeries of interest (valvular, coronary bypass, aortic or combined surgery) will be randomized to 2 paralell arms : - Perioperative anesthesia with a BIS (Bispectral index) target of 35 - Perioperative anesthesia with a BIS(Bispectral index) target of 55 The presence of mental confusion will be determined by CAM-ICU ( Confusion Assessment Method for the ICU ) at day 3 post procedure. Ancillary study: To assess cognitive status at inclusion, discharge and third post operative month using the MOCA(Montreal Cognitive Assessment ). Conclusion:The hypothesis of this study is that a lower depth of anesthesia will reduce post operative delirium in the first three days in patients older than 75 years who are planned for valvular, coronary artery bypass, aortic or combined cardiac surgery .

NCT ID: NCT05872529 Not yet recruiting - Delirium Clinical Trials

Turkish Precision Anaesthesia Study Project

TuPASProject
Start date: July 2023
Phase: N/A
Study type: Interventional

Postoperative delirium (POD) and postoperative neurocognitive disorder (PND) increase the length of hospital stay, morbidity and mortality, especially in elderly patients. Although several risk factors were determined and incidence trials were performed on the development of POD and PND, there has not yet been a multicentre, large-participant study in Turkish population. The SBI approach monitor, detect and help physicians and all perioperative team members to decrease and avoid the adverse side effects of surgery and anaesthesia. In this "before and after" design trial the incidence of POD and PND will be compared before and after education which consists processed EEG and SBI approach. The primary aim of the study is to determine the effect of education which consists processed EEG monitoring and regularly assessment of patient's stress, anxiety, pain, nausea, vomiting, thirst, hunger and better communication at the pre- and postoperative period on the incidence of POD. The secondary aim of the study is to assess the effect of the Safe Brain Initiative approach on patients' thirst feeling, stress-anxiety levels, postoperative pain, postoperative nausea and vomiting, well-being, satisfaction, length of PACU or recovery room stay, length of hospital stay, incidence of PND and in hospital and 3-month mortality. Also, the physicians', nurses' and patients satisfaction will be assessed.

NCT ID: NCT05841368 Not yet recruiting - Delirium Clinical Trials

DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC

DELUSION
Start date: January 1, 2024
Phase:
Study type: Observational

Delirium in intensive care unit (ICU) settings is a frequent complication with reported prevalence of 31%. Recent data has revealed the connection between delirium and increased 30days mortality after hospital release and the higher incidence of readmission to emergency. Despite the high prevalence and well described validation methods for screening, the precise incidence remains unclear due to insufficient screening in ICU settings. The incidence of delirium in Czech Republic remains undescribed, beside data reported from neurointensive care patients and single-center general critically ill patients data.

NCT ID: NCT05821972 Not yet recruiting - Sedation Clinical Trials

Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

Start date: May 15, 2023
Phase: Phase 4
Study type: Interventional

To compare the efficacy of the pre-operative nebulization of a combination of dexmedetomidine and ketamine versus nebulization of dexmedetomidine alone for sedation and prevention of emergence delirium in children undergoing cleft palate repair surgeries.

NCT ID: NCT05819723 Not yet recruiting - Delirium in Old Age Clinical Trials

Erector Spinae Block and Incidence of Postoperative Delirium After Hip Fracture Surgeries

Start date: May 1, 2023
Phase: N/A
Study type: Interventional

Postoperative pain is a significant risk factor for delirium. This clinical trial will search whether analgesia produced by erector spinae block in elderly patients undergoing hip fracture surgeries reduces delirium or not!

NCT ID: NCT05806827 Not yet recruiting - Clinical trials for POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE

INVESTIGATE THE ASSOCIATION BETWEEN VIRAL NEUROTOXIC INFECTION AND POSTOPERATIVE DELIRIUM AND POSTOPERATIVE COGNITIVE DECLINE

CONNECTED
Start date: March 1, 2024
Phase:
Study type: Observational

In the last two decades, viral infections have increased dramatically : the 2003 severe acute respiratory syndrome coronavirus outbreak, the 2009 swine flu pandemic, the 2012 Middle East respiratory syndrome coronavirus outbreak, the 2013-2016 Ebola virus disease epidemic in West Africa and the 2015 Zika virus disease epidemic and not least the COVID-19 pandemic. At the same time, neurological disorders are a major and increasing global health challenge, which accounts for a substantial portion of the disease burden worldwide . In Europe, more than half of the population (approx. 60% ) suffers from a neurological disease, ranking number three among all disease groups . The figures are higher in the population with more than 65 years. Based on Eurostat annual publication "Aging Europe", in 2020 people over 65 represented 20.6% of the European Union population, and the projections show that the share of people over 65 is expected to strongly increase until 2058, reaching 30.3% of the EU population. Furthermore, while in civil aviation, the mortality rate is estimated around 0,00525% (Eurocontrol, 2022), the perioperative mortality rate in Europe is about 4% (Pearse et al., 2012). Clearly, the patients undergoing surgery already have a higher mortality risk depending on their initial medical conditions. However, the medical field can without doubts benefit from an improved risks assessment approach derived from the civil aviation. Against this backdrop, the project aims at: i) researching the correlation between a neurotoxic viruses' infection and the increased risk, in terms of frequency or severity, of developing a cognitive disfunction such as the postoperative cognitive dysfunction (POCD), by conducting an observational clinical trial on selected neurotoxic viruses (SARS-CoV-2, Herpes simplex virus, Cytomegalovirus and Epstein Barr virus). ii) developing a theoretical model for monitoring the implications of general anaesthesia in elder patients aged ≥ 65 years iii) designing a risk assessment mechanism, based on the best practices developed in the aerospace sector, for patients with neurotoxic infection and POCD, that can be furtherly scalable in other medical contexts. iv) building an AI-based platform, following the example of the NSQIP risk calculator for cardiovascular postoperative complications, both for data collection and data processing, able to return an estimate of the risk of perioperative-related cognitive complications in elder patients undergoing major elective surgeries. Observational Clinical Trial The clinical trial will recruit a sample of 1685 patients in eight centres (about 250 patients per centre, considering also the drop-out rate) to be finalised in 24 months. The primary end point of the clinical trial is to evaluate if patients undergoing general anaesthesia for elective major surgeries lasting longer than 1 hour that have an history of COVID-19 (not an active SARS-CoV-2 infection) do have a higher risk to develop postoperative cognitive dysfunction (POCD)/delayed neurocognitive recovery (DNC) at 3 months and 6 months follow up after surgery. Secondary end point include: 1. - Relationship between POCD/DNC with preoperative exposure to other neurotropic viruses: Herpes simplex virus (HS), Cytomegalovirus (CMV), and Epstein Barr virus (EBV). 2. - Development -on the basis of collected data- of a software dedicated to calculating in the preoperative phase the risk for early postoperative delirium or POCD/PNDs. 3. - Development of a conceptual model of "perioperative safety management": as in civil aviation traffic control, increasing the patients' perception of healthcare safety and quality. 4. - Delivery of training to healthcare practitioners concerning the preoperative evaluation of POD risk and the identification of patients at risk.

NCT ID: NCT05772026 Not yet recruiting - Clinical trials for Postoperative Delirium

Plasma Proteomics in Patients With Postoperative Delirium

Start date: March 20, 2023
Phase:
Study type: Observational

Patients undergoing cardiac surgery were recruited. Baseline characteristics of all subjects were collected. The 3-minute Delirium diagnostic Scale (3D-CAM) was used to screen the POD group and non-POD group from the recruited subjects during the first 7 days after surgery. Peripheral blood samples were collected 1 day before surgery and 2 day after surgery. . Plasma was isolated from peripheral blood for subsequent proteomic analysis.

NCT ID: NCT05594966 Not yet recruiting - Clinical trials for Postoperative Delirium

Neuroimaging Combining Biomarkers for Identifying Long-term Cognitive Dysfunction and Delirium

NeuroIDEA
Start date: November 2022
Phase:
Study type: Observational

Postoperative Cognitive Dysfunction(POCD) is commonly seen in cardiac surgery, which may lead to poor pognosis. Cerebral small vessel disease(CVSD) is refer as the main resource of delirium among elderly people. In the study, CVSD will be diagnosed using multimodal MRI. And we want to select a high correlating COPD biomarker through CyTOF. We also want to investigate a medical model to select the high risk patients who may suffer from POCD after cardiac surgery.

NCT ID: NCT05582005 Not yet recruiting - Pain Clinical Trials

An Observational Study of Emergence and Hypoactive Delirium After Anesthesia

Start date: December 2022
Phase:
Study type: Observational

Early postoperative negative behaviour (ePONB), such as pain, emergence delirium (ED) and hypoactive delirium, is a relevant clinical problem during recovery from anesthesia. Specifically, many children often present with different forms of negative behavior namely ED, hypoactive delirium or pain. Such negative behavior differs in terms of evolution, treatment, prognosis and clinical implications. Furthermore, there is overlap between tools used to measurement postoperative pain and ED. As a result, the assessment of the different forms of negative behavior are often compromised by the presence of postoperative pain. Therefore, the application of scales used to measure negative behaviour in postanesthetic, non-surgical patients aged 3 years and under scheduled for elective MRI may clarify the presence of ED, hypoactive delirium and pain. An improved understating of postanesthetic negative behavior is important in order to help implement appropriate measures so as to better treat these patients.