Clinical Research Directory

Effects of Remimazolam on Postoperative Cognitive Dysfunction and Neuroinflammatory Biomarkers in Patients Undergoing Aortic Arch Surgery

The purpose of this study is to compare remimazolam- and propofol-based anesthesia for their effects on postoperative cognitive dysfunction in patients undergoing aortic arch surgery. These procedures involve a substantial risk of cerebral ischemia and reperfusion injury, which may contribute to postoperative cognitive decline. Although experimental studies have suggested potential neuroprotective effects of remimazolam, clinical evidence in patients undergoing high-risk aortic arch surgery remains limited. This prospective, randomized controlled trial will compare the incidence of postoperative cognitive dysfunction between patients receiving remimazolam- or propofol-based anesthesia. In addition, changes in circulating neuroinflammatory and neuronal injury biomarkers will be evaluated to explore the potential mechanisms underlying any neuroprotective effect of remimazolam. The findings may provide clinical evidence to guide anesthetic selection and improve neurological outcomes in patients undergoing aortic arch surgery.

Acetaminophen-Mannitol Injection and Postoperative Delirium

The aim of this multicenter randomized controlled study is to evaluate the effect of an intravenous acetaminophen-mannitol opioid-sparing analgesic strategy on the cumulative incidence of POD, compared with an intravenous sufentanil-based opioid analgesic strategy.

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.

Creatine and Perioperative Brain Health

The overall goal of this study is to explore the effects of perioperative oral creatine supplementation 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.

Mechanisms and Intervention Strategies of Perioperative Glycemic Variability on Postoperative Delirium

Delirium is a sudden change in attention, thinking, and awareness that can occur after heart surgery. It may slow recovery and is associated with longer hospital stays and poorer health outcomes. Patients undergoing heart surgery with cardiopulmonary bypass, also known as a heart-lung machine, may experience changes in blood sugar levels and in the body's response to insulin around the time of surgery. This study aims to investigate how fluctuations in blood sugar levels, known as glycemic variability, are related to postoperative delirium. It will also examine whether insulin resistance, a condition in which the body responds less effectively to insulin, helps explain this relationship. The study will evaluate intranasal insulin, which is insulin administered through the nose to reach the brain. Researchers will assess its effects on blood sugar fluctuations, insulin resistance, and the occurrence of postoperative delirium in patients undergoing heart surgery with cardiopulmonary bypass. The findings may help guide future approaches to protecting brain function and improving recovery after heart surgery.

Liposomal Bupivacaine Fascia Iliaca Block for Perioperative Sleep Quality in Elderly Patients With Intertrochanteric Fracture

Older adults with hip fracture often experience severe pain before and after surgery. This pain can cause anxiety and poor sleep, and may increase the risk of postoperative delirium (sudden confusion after surgery). A fascia iliaca compartment block (FICB) is an injection of numbing medicine near the hip nerves that relieves pain, but standard numbing medicines only last about 8 to 12 hours. Liposomal bupivacaine is a long-acting form of a numbing medicine that may relieve pain for up to 72 hours after a single injection. This study tests whether giving an ultrasound-guided FICB with liposomal bupivacaine immediately after hospital admission (before surgery) improves sleep quality, reduces anxiety and pain, lowers the need for opioid pain medicines, and reduces postoperative delirium in patients aged 65 to 80 years undergoing surgery for intertrochanteric hip fracture, compared with a placebo (saline) injection. All participants in both groups receive the same standard pain treatment, including scheduled intravenous dexketoprofen and patient-controlled analgesia after surgery.

Digitalized Clinical Decision Support for the Prevention of Postoperative Delirium (POD)

The project aims to improve patient safety, reduce barriers to the implementation of current guideline recommendations, reduce workload in clinics, increase efficiency in work processes and close gaps in care. Subprojects regarding delirium are implementes as well.

The Relationship Between Zonulin and Interleukin-8 Levels and Postoperative Delirium Development

The relationship between zonulin and interleukin-8 levels and postoperative delirium development in patients who had femur fracture surgery under regional anesthesia

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.

Music Intervention to Reduce Anxiety and Prevent Delirium in Older Adults Undergoing Cardiac Surgery

The goal of this clinical trial is to evaluate the effectiveness of the music intervention in preventing postoperative delirium (POD) in older patients undergoing elective cardiac surgery. The primary question is: Among older adults undergoing elective cardiac surgery, does offering a structured perioperative music intervention in addition to standard care reduce the incidence of POD within the first five postoperative days compared with standard care alone? The secondary questions are: Does perioperative music intervention reduce preoperative anxiety (PA) among older patients undergoing cardiac surgery, and does the level of PA moderate the effect of the music intervention on POD? Researchers will compare music intervention to routine care to see if music intervention can reduce PA and prevent POD. Participants will listen to music before and after surgery, be assessed for PA and POD, and participate in an interview about participants' perspectives on the music intervention.

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.

The Impact of Repetitive Transcranial Magnetic Stimulation on the Prognosis of Elderly Surgical Patients

Exploring the effects of repeated transcranial magnetic stimulation (rTMS) during the perioperative period on the incidence of postoperative delirium, postoperative cognitive dysfunction, and chronic postoperative pain in elderly patients, as well as its possible mechanisms.

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).

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.

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.

Cerebral Oximetry During Awake Carotid Endarterectomy

Surgery to remove plaque from the carotid artery in the neck requires the artery to be clamped for a period of time. In some patients this reduces blood flow to the brain enough to cause temporary symptoms, and a temporary plastic tube called a shunt has to be inserted to restore flow. When the operation is performed with the patient awake under a local anaesthetic block, doctors decide whether a shunt is needed by talking to the patient and testing the strength of the hand on the opposite side during clamping. This is called the awake neurological test. A device called a cerebral oximeter can measure the oxygen level in the front part of the brain continuously and without needles, using light shone through the forehead. It has been suggested as a way of detecting reduced brain blood flow during this operation, and would be particularly useful for patients who are asleep under general anaesthesia and cannot be tested. However, previous studies have often chosen their alarm level after looking at their own results, and have often allowed the operating team to see the oximeter readings, which makes the results appear better than they really are. In this study, 150 adults having planned carotid surgery under a local anaesthetic block will have a cerebral oximeter attached to the forehead throughout the operation. The screen will be covered so that neither the anaesthetist nor the surgeon can see the readings, and the decision to insert a shunt will be based only on the awake neurological test, exactly as it is now. The oxygen readings will be stored inside the device and examined only after the operation. The main question is how accurately a fall of 20% or more in brain oxygen level, a level chosen in advance from previous published research, identifies the patients whose awake test becomes abnormal during clamping. The second question is whether the total amount of low brain oxygen during clamping is related to confusion or stroke in the first three days after surgery, and to memory change one month later. Participants complete a short memory test before the operation and again at one month, using different versions of the test on each occasion.

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.

Intraoperative Dexmedetomidine Use, MMP-8, and Postoperative Delirium After Cardiac Surgery With Cardiopulmonary Bypass

This observational study evaluated the association between intraoperative dexmedetomidine use and postoperative delirium (POD) in adults undergoing cardiac surgery with cardiopulmonary bypass (CPB). The study included two linked clinical components. First, routinely collected clinical data from patients undergoing cardiac surgery with CPB at three campuses of Tongji Hospital between January 2015 and December 2022 were analyzed to evaluate the dexmedetomidine-POD association. Second, perioperative plasma samples and clinical data from a prospective observational cohort enrolled between April 2023 and September 2024 were used to characterize perioperative matrix metalloproteinase-8 (MMP-8) dynamics and their associations with intraoperative dexmedetomidine use and POD. Dexmedetomidine administration was determined by the attending anesthesiologist according to clinical judgment and routine anesthetic practice and was not assigned by the study protocol.

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.

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.