Clinical Research Directory

BrainProtect-guided, Real-time Cerebral Autoregulation Monitoring and Protection of Brain During Cardiac Surgery With Cardiopulmonary Bypass Requiring Heart-lung Machine

The purpose of this clinical investigation is to evaluate the clinical performance, safety, and clinical benefit of the BrainProtect System in reducing early postoperative neurological complications in adult participants undergoing elective coronary artery bypass grafting (CABG) with cardiopulmonary bypass (CPB). The investigation aims to verify the claim that real-time detection and correction of cerebral autoregulation (CA) impairment during CPB improves neurological outcomes compared to standard perioperative management. The study is designed to demonstrate superiority of BrainProtect-guided management over standard care. This is a Multicenter, two-arm, blinded, randomized controlled pivotal (confirmatory) clinical investigation of a non-CE marked investigational medical device. Adult participants undergoing elective coronary artery bypass graft (CABG) surgery requiring cardiopulmonary bypass (CPB) will be randomized in a 1:1 ratio to either the investigational group or the control group. In the investigational group, standard perioperative management during CABG with CPB will be performed. Real-time cerebral autoregulation (CA) monitoring using the BrainProtect System will be applied during CPB. In the control group, standard perioperative management during CABG with CPB will be performed. Conventional systemic hemodynamic monitoring will be used. The BrainProtect System will not be used, and no real-time cerebral autoregulation monitoring data will be available to the clinical team. Postoperative neurological outcomes (POCD and POD) will be assessed in both groups using predefined standardized neuropsychological tests and CAM-ICU assessments during the early postoperative period. In addition, the length of the index hospitalisation and occurrence of hospital readmission within 31 days after surgery and the reason for readmission will be recorded.

Transcranial Doppler and Artificial Intelligence Prediction of Postoperative Delirium in Heart Valve Surgery

Postoperative delirium is a frequent complication after cardiac surgery. This prospective observational study will evaluate whether cerebral blood flow velocity measured by transcranial Doppler before and during elective heart valve surgery is associated with delirium during the first five postoperative days. Bispectral index, near-infrared spectroscopy, and arterial blood gas data will also be recorded. Delirium will be assessed daily by an independent evaluator who is blinded to the intraoperative measurements and artificial intelligence predictions, using CAM-ICU for mechanically ventilated patients or the Turkish 3D-CAM for patients on the ward. The study will also compare zero-shot delirium risk predictions from five general-purpose large language models (Claude, GPT, Gemini, Grok, and Kimi) with the blinded clinical assessments. The models will not be trained on data from the study cohort.

Postoperative Delirium and Analgesia in Elderly Patients

This study aims to evaluate the effects of different postoperative analgesic approaches on postoperative delirium in elderly patients undergoing total knee arthroplasty.

CEReBral AutorEgulation in Non-cardiac SuRgery and Relationship to Postoperative DeliriUm State

The goal of this observational study is to learn the how to determine the mean arterial pressure(MAP) or blood pressure level to be maintained during non-cardiac surgery for optimal brain health in patients above the age of 60 undergoing major non-cardiac surgery. The main question\[s\] it aims to answer are: * Is there a way to tailor the blood pressure to be maintained in such patients during surgery for optimal brain health using non-invasive monitors that check the brains electrical activity, the electroencephalogram(EEG) monitor, and the brain's blood oxygen levels, the cerebral oximetry(CO) monitor? * How much does this optimal blood pressure level vary between patients? Participants will be asked to: * Complete a questionnaire at the time they enroll into the study, as well as a daily questionnaire to help determine their level of thinking and brain health. This questionnaire will be administered by a member of the study team. * They will also have an EEG and CO monitoring sticker placed on their foreheads. This will be connected to a monitor that will collect this data just before, during, and after their surgery. The data collected through these monitors will help us with our study goals.

Cytokines, POD, Health Status, Older Hip Fracture

An investigation of the change in inflammation marker levels across hip fracture surgery and an exploration of any association with change in self reported health status and incidence of postoperative delirium

Remimazolam for Reducing Postoperative Delirium in Elderly Patients Undergoing Laparoscopic Gastrectomy

This prospective, single-center, randomized, participant- and outcome assessor-blinded, parallel-group controlled trial evaluated whether remimazolam-based anesthesia reduced postoperative delirium (POD) and improved peri-induction hemodynamic stability compared with propofol-midazolam-based anesthesia in patients aged 65 years or older undergoing elective laparoscopic radical gastrectomy for gastric cancer. A total of 147 participants were randomized in a 1:1 ratio. Standardized perioperative management, BIS-guided anesthetic depth control, and postoperative analgesia were applied in both groups. The primary outcome was the cumulative incidence of POD during postoperative days 1-3, assessed once daily using the 3D-CAM or CAM-ICU by trained outcome assessors blinded to treatment allocation. Secondary outcomes included post-induction hypotension, peri-induction hemodynamic variables, postoperative recovery, pain scores, and adverse events.

A Clinical Trial of Intravenous Lidocaine After Spinal Surgery to Prevent Delirium and Reduce Pain

Postoperative delirium is one of the most frequent adverse events following elective non-cardiac surgery and is associated with cognitive impairment at discharge, as well as in-hospital and long-term mortality, however, despite being a well-recognized problem there is a dearth of effective interventions for prevention and management. A modifiable risk factor associated with postoperative delirium is poor postoperative pain control, and by improving the pain regimen the investigators may be able to decrease the incidence and/or severity of postoperative delirium. In this study, the investigators seek to study whether a postoperative intravenous infusion of lidocaine, known to improve pain control in other contexts, can decrease the risk of postoperative delirium and other opioid-related side effects, following major reconstructive spinal surgery.

Digital Sleep Optimization for Brain Health Outcomes in Older Surgical Patients

The Sleep Optimization for Brain Health Outcomes in Older Surgical Patients (SLEEP-BOOST) is a pilot randomized, controlled, singled-blinded (participant) trial in major orthopedic joint surgery patients that will build on a previously clinically tested cognitive behavioral therapy for insomnia (CBT-I) mobile application paired with a wearable device (wrist actigraphy).

Preoperative Distress and Postoperative Delirium in Elderly Patients Undergoing Major Orthopedic Surgery

Postoperative delirium is a common and serious complication in elderly patients undergoing major orthopedic surgery and is associated with increased morbidity, prolonged hospital stay, and higher healthcare costs. Preoperative psychological distress has been suggested as a potential risk factor influencing postoperative outcomes; however, its relationship with delirium and other clinical outcomes remains insufficiently explored. This prospective observational study aims to investigate the association between preoperative distress levels and postoperative delirium, pain intensity, and length of hospital stay in elderly patients undergoing major orthopedic surgery. Preoperative distress will be assessed using validated tools, and postoperative outcomes including delirium incidence, pain scores, and hospital stay duration will be recorded and analyzed. The findings of this study are expected to contribute to improved perioperative risk stratification and may support the development of targeted interventions to reduce postoperative complications in this vulnerable patient population.

Dexmedetomidine in Reducing Postoperative Delirium in Cardiac Surgery Patients

Delirium is a common consequence of cardiac surgery and associates with poor outcomes. Multiple causes can trigger delirium occurence, and it has been hypothesised that sleep disturbances can be one of them. Dexmedetomidine may be effective in reducing delirium. The aim of this study was to demonstrate preoperative dexmedetomidine nasal spray in cardiac surgery patients can reduce postoperative delirium by improving preoperative sleep.

Intrathecal Dexmedetomidine and Postoperative Delirium in Elderly Hip Fracture Surgery

Postoperative delirium (POD) is a common and serious complication in elderly patients undergoing surgical repair for hip fractures, often triggered by acute pain, surgical stress, neuroinflammation, and opioid consumption. Although spinal anesthesia using bupivacaine is commonly performed, local anesthetics alone often require additional systemic rescue opioids for postoperative pain relief, which can further increase delirium risk. Dexmedetomidine is a selective alpha-2 adrenergic agonist that has demonstrated neuroprotective, anti-inflammatory, and opioid-sparing effects. The purpose of this clinical trial is to evaluate whether adding intrathecal dexmedetomidine as an adjuvant to hyperbaric bupivacaine during spinal anesthesia reduces the incidence and severity of postoperative delirium compared to hyperbaric bupivacaine alone in geriatric patients undergoing hip fracture surgeries. Participants will be randomly assigned to one of two groups: * Dexmedetomidine Group: Receives hyperbaric bupivacaine 0.5% (10 mg) combined with 5 µg dexmedetomidine intrathecally. * Control Group: Receives hyperbaric bupivacaine 0.5% (10 mg) combined with normal saline intrathecally. The primary outcome is the incidence of postoperative delirium evaluated using the Confusion Assessment Method (CAM) twice daily during the first 48 hours following surgery. Secondary assessments include the duration and severity of delirium episodes, spinal block characteristics, hemodynamic stability, postoperative pain scores, rescue analgesic consumption, sedation levels, adverse events, and total hospital length of stay.

Minimizing ICU Neurological Dysfunction With Dexmedetomidine-induced Sleep

This study aims to determine whether, compared with placebo, the nighttime administration of a intravenous dexmedetomidine is effective at inducing sleep and preventing postoperative delirium in extubated post-cardiac surgical patients.

Anesthesia and Postoperative Delirium in Parkinson DBS

Parkinson's disease (PD) is the second most common neurodegenerative disorder, with a rising incidence due to global aging. Deep Brain Stimulation (DBS) of the subthalamic nucleus (STN) is a core therapeutic modality for motor symptoms in patients with moderate-to-advanced PD. However, Postoperative Delirium (POD) is a common and significant complication following DBS surgery, affecting up to 42.6% of patients. POD is associated with prolonged hospitalization, increased medical costs, and poorer neurological prognosis. Current evidence regarding the incidence of POD after STN-DBS and the impact of different anesthesia management strategies remains limited, with a lack of large-scale prospective studies. This study aims to prospectively investigate the incidence, risk factors, and anesthesia-related neuroprotective mechanisms of POD in PD patients undergoing STN-DBS. Specifically, the study seeks to: Determine the incidence of POD within 3 days postoperatively. Analyze the correlation between anesthesia management (including anesthetic agents, depth, and hemodynamics) and the occurrence of POD. Explore the interaction between POD and postoperative non-motor symptoms such as pain, sleep disturbances, and long-term cognitive function. Construct a multidimensional prediction model for POD based on preoperative and intra-operative data.

Intraoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients

Postoperative delirium (POD) is a common surgical complication. The incidence is 10% to 22% in neurological procedures, and advanced age is a risk factor for neurological procedures. Many studies have shown that dexmedetomidine(DEX) may reduce the incidence of delirium in non-cardiac surgery patients and elderly patients. However, there are few studies focus on the effect of DEX on POD in elderly patients undergoing neurosurgery. The purpose of this study was to investigate the effect of DEX on POD in in elderly patients undergoing craniotomy.

Evaluation of a Hospital Program to Prevent Postoperative Delirium in Older Patients

Postoperative delirium is a common complication in older adults undergoing surgery. It is characterized by an acute and fluctuating disturbance of attention, awareness, and thinking. Delirium may be associated with prolonged hospital stay, loss of independence, cognitive decline, complications, and increased need for care. The University Medical Center Hamburg-Eppendorf has introduced a multicomponent care program to prevent postoperative delirium in patients aged 65 years and older. The program includes preoperative assessment of risk factors such as frailty, cognitive impairment, and malnutrition, as well as information for patients and relatives. Depending on the individual risk profile, preventive measures may include support with orientation, adequate hydration and nutrition, early mobilization, preservation of the sleep-wake cycle, use of glasses and hearing aids, avoidance of unnecessary room changes, and reduction of medications that may contribute to delirium. A specialized delirium team supports patients and clinical staff during the hospital stay. EvaDel is a prospective study evaluating how patient care and clinical outcomes change while this delirium prevention program is gradually implemented in routine clinical practice. Participants will be followed from before surgery until three months after the operation. The study will assess the occurrence of postoperative delirium, cognitive function, independence in everyday activities, postoperative complications, and the extent to which the preventive measures were successfully implemented. The study hypothesis is that a higher degree of implementation of the delirium prevention program will be associated with a lower rate of postoperative delirium and with better cognitive, functional, and clinical outcomes after surgery.

Dexmetomedine for Post Operative Delirium in Elderly Patients Undergoing Elective Total Knee Replacement Under Spinal Anesthesia

Postoperative delirium is a geriatric syndrome occurring after anesthesia and surgery which manifests as acute alterations in mental status, involving changes in cognition, attention, and levels of consciousness that tend to fluctuate The use of dexmedetomidine with the intention to prevent postoperative delirium remains controversial. Where it has shown to be effective in older adult patients undergoing cardiovascular and non-cardiovascular surgeries

Perioperative Transcranial Photobiomodulation and Delayed Neurocognitive Recovery in Older Patients

Delayed neurocognitive recovery is a common neurocognitive complication in older patients after surgery, especially those with preoperative neurocognitive decline. Transcranial photobiomodulation therapy is a novel neuromodulation technique using transcranial low-power light to modulate brain biological functions. This technique has been used to treat various neurological or psychiatric conditions, including ischemic stroke, traumatic brain injury, and major depression. This study is designed to explore whether using transcranial photobiomodulation therapy during the perioperative period can reduce the incidence of delayed neurocognitive recovery in older patients with pre-existing neurocognitive impairment.

Creatine and Perioperative Brain Health

The overall goal of this study is to evaluate the feasibility of perioperative oral creatine supplementation and to explore its effects on cognitive function and physiological responses to surgery in older adults. Creatine is commonly used to enhance athletic performance, but it can also have positive effects on the brain. Since surgery can alter thinking, memory, and attention patterns in some patients, we will assess whether creatine affects these changes in older adults undergoing surgery.

Correlation Between Preoperative Sleep and Postoperative Brain and Renal Dysfunction

To explore the correlation between preoperative sleep parameter clustering and postoperative brain and renal dysfunction.

Inflammatory Biomarkers and Postoperative Delirium in Pediatric Circumcision

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.

Postoperative Delirium in Patients Undergoing Cardiac Surgery

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.

Efficacy of Suvorexant on Post-operative Sleep Disturbance

The study is a parallel group, double blind, randomized trial. Subjects will be recruited from individuals undergoing elective surgery for orthopedic, abdominal, urologic, gynecologic or spine reasons. Out of 92 subjects, one experimental group of 46 subjects will receive 20 mg Suvorexant beginning the first in-hospital night ("day 0") and continuing for their hospital stay. If the dose is not well tolerated (e.g., daytime sleepiness), then the dose may be decreased to 10 mg of Suvorexant. For blinding purposes each arm will receive two tablets (two 10 mg tablets or one 10 mg tablet and a placebo). The other control group of 46 subjects will receive placebo (two tablets) and treatment as usual.

Recovery After Upper Extrimety Surgery

The goal of this randomized clinical trial is to determine whether Bispectral Index (BIS)-guided general anesthesia improves postoperative cognitive recovery and overall quality of recovery in adults undergoing elective hand or arm surgery. The main questions it aims to answer are: Does BIS-guided anesthesia improve postoperative cognitive recovery compared with general anesthesia guided by routine clinical signs? Does BIS-guided anesthesia improve overall postoperative recovery, as measured by the Postoperative Quality of Recovery Scale (PQRS)? Researchers will compare patients receiving BIS-guided general anesthesia with patients receiving clinically guided general anesthesia, in which the BIS monitor records data but the displayed values are concealed from the anesthesia team, to determine whether BIS-guided anesthetic management improves postoperative recovery. An additional comparison group will consist of patients undergoing surgery under intravenous regional anesthesia without general anesthesia. Participants will: undergo elective hand or arm surgery; receive either BIS-guided or clinically guided general anesthesia, or intravenous regional anesthesia without general anesthesia; complete PQRS assessments before surgery and at multiple postoperative time points, including follow-up for up to three months.

The Caffeine, Postoperative Delirium, and Change in Outcomes After Surgery (CAPACHINOS-2) Study

The objective of this study is to test the effects of caffeine on neurocognitive and clinical recovery after major surgery. Specifically, this trial tests the primary hypothesis that caffeine will reduce the incidence of postoperative delirium.