Clinical Research Directory

Verification of a New Predictive Delirium Score in Adults With Elective Cardiac Valve or Bypass Surgery With Perioperative Use of a Heart-lung Machine; a Monocentric Pilot Observational Study

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

The Occurrence of Emergence Agitation in Pediatric Strabismus Surgery

The present trial conducted to demonstrate the administration of sugammadex as reversal of neuromuscular blockade agent reduces the incidence of emergence agitation (EA) comparing to neostigmine

Efficacy of Ultrasound-guided Greater Auricular Nerve Block in Preventing Postoperative Emergence Agitation in Pediatric Patients Undergoing Microscopic Middle Ear Surgery.

This study is designed to evaluate the effectiveness of ultrasound-guided greater auricular nerve block (GAN) on the reduction of emergence agitation (EA) occurrence and EA severity in children who are receiving general anesthesia for a microscopic middle ear operation.

Dexmedetomidine-Midazolam vs. Ketamine-Midazolam on Emergence Delirium

Fifty children undergoing heart catheterization without local anesthesia in the skin will be randomly divided into two groups. Group DM (Dexmedetomidine + Midazolam) and Group KM (Ketamine + Midazolam)

Decreasing Emergence Delirium With Personalized Music

This is a prospective randomized controlled trial in children 3-9 years of age undergoing myringotomies at Washington University in St. Louis to assess the impact of perioperative personalized music on the incidence of emergence agitation.

Transcutaneous Auricular Vagus Nerve Stimulation for Prevention of Emergence Agitation and Delirium in Children Undergoing Tonsillectomy and Adenoidectomy

Brief Summary This study is designed to find out whether transcutaneous auricular vagus nerve stimulation (taVNS) can safely reduce restlessness and confusion when children wake up from anesthesia after tonsillectomy and adenoidectomy. These problems, called emergence agitation and delirium, are common after surgery and can cause distress for both children and their families.TaVNS is a non-invasive treatment that delivers mild electrical stimulation to a specific area of the ear connected to the vagus nerve. It does not involve needles or medication, and children usually feel only a gentle tingling sensation.In this randomized, double-blind study, children will be assigned by chance to receive either taVNS or a sham (placebo) stimulation during surgery. Neither the children, their families, nor the medical team providing care will know which treatment each child receives.Researchers will observe and record how calmly children wake up from anesthesia, whether they show signs of delirium, and any side effects. The goal of this study is to test whether taVNS is an effective and safe way to improve recovery and comfort for children after surgery.

Language During Inhalational Induction

The aim of this study is to compare the impact of common (standard of care) language vs positive language used by clinicians during inhalational induction of anesthesia on anxiety and negative behaviors in children. This is a prospective randomized parallel group trial. Patients will be randomized 1:1 to the common/standard language group or the positive language group.

Opioid Sparing Anesthesia Care for Pediatric Patients Having Tonsil Surgery

This is a prospective, randomized, controlled, non-inferiority study of patients undergoing tonsil surgeries at Boston Children's Hospital Waltham. The overall aim is to evaluate the efficacy of an opioid anesthetic plan (morphine, ketorolac, and acetaminophen versus an opioid sparing anesthetic plan (dexmedetomidine, ketorolac and acetaminophen) for perioperative analgesia and recovery time in patients undergoing tonsillectomies and tonsillotomies at Boston Children's Hospital Waltham. Secondary measures include rescue opioids administered in post-anesthesia care unit (PACU), re-operation secondary to bleeding, emergence delirium, post-operative nausea and vomiting, intraoperative hemodynamics, intraoperative vasopressor administration, and length of procedure.

Effect of FPCA on Incidence of Emergency Delirium in Children After Surgery

Emergence delirium (ED) stands out as a prevalent postoperative complication among paediatric patients, correlating with extended hospitalization periods, escalated healthcare expenses, and increased incidence of postoperative maladaptive behaviours (POMBs). There is a lack of well-established pharmacological or non-pharmacological interventions demonstrating efficacy in reducing the occurrence of ED. Therefore, our objective is to assess the potential of family-centred perioperative care for anaesthesia (FPCA) in mitigating the incidence of ED in children, compared with routine anaesthesia.

Nebulized Dexmedetomidine Combined With Ketamine Versus Nebulized Dexmedetomidine for Cleft Palate

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.

Remimazolam and Emergence Delirium in Pediatrics

Emergence delirium is a common complication in pediatrics undergoing neurosurgery. Previous study showed that a single bolus of remimazolam was associated with lower incidence of postoperative agitation. Present study was designed to investigate if remimazolam supplemented to sevoflurane anesthesia could decrease the risk of emergence delirium in pediatrics undergoing neurosurgery.

Intraoperative Diagnosis of Neurocognitive Complications Via Electroencephalographic Analysis

Postoperative neurocognitive disorders (PND) are serious and common complications after surgery, especially in elderly patients. These disorders can affect cognitive functions for years, deteriorating quality of life and increasing hospital stays and medical costs. Diagnosing PND is challenging due to their varied manifestations, such as memory and attention problems, and the lack of standardized criteria and biomarkers. One well-studied form of PND is postoperative delirium (POD). According to the ICD-10, POD is an organic cerebral syndrome characterized by disturbances in consciousness, attention, perception, and other cognitive functions. Researchers suggest that POD development involves a combination of predisposing and precipitating factors. Electroencephalography (EEG) has been used in anesthesiology to assess anesthesia depth and intraoperative awareness. Modern EEG analysis methods, like spectral analysis, offer new ways to evaluate patients' neurophysiological states. Studies show that EEG monitoring can predict complications such as intraoperative stroke and delirium, particularly in cardiothoracic and neurosurgical operations. The relationship between EEG patterns and POD is not well understood. Specific EEG patterns may indicate the risk of POD, aiding in the identification of risk factors and prevention methods. This could help anesthesiologists and surgeons optimize their approaches, reducing the risk of cognitive complications.

Prognosis of Patients Who Presented With a State of Extreme Agitation.

The main objective is to assess the 6-month prognosis of patients who presented with extreme agitation in the emergency room. The primary endpoint is the 6-month mortality of agitated patients.

Post Operative Cognitive Dysfunction After Breast Surgery

Aim of this trial is to define if Post-Operative Cognitive Dysfunction, detected analyzing changes between pre-operative and post-operative Neurocognitive Test, and Postoperative Delirium, relate to concentration of effector's site concentration of propofol and remifentanil TCI and to the common intraoperative neuromonitoring values as well as to Pupillometry values (in particular Pupil Diameter, Pupil Latency, and Maximum Contraction Velcoity).

MELAtonin for Prevention of Postoperative Agitation and Emergence Delirium in Children

Postoperative agitation and emergence delirium describe a spectrum of symptoms of early postoperative negative behavior, in which the child experiences a variety of behavioral disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. The symptoms are common with a reported incidence of approximately 25%. Some clinical trials have studied the effect of prophylactic oral melatonin for reducing the risk of emergence agitation in children, some finding a considerable dose-response effect. Melatonin has a low bio-availability of approximately 15 %. The safety of exogenous melatonin for pediatric patients has been studied with no apparent serious adverse effects, even at repeated short-term use of high doses of intravenous melatonin. The aim of this clinical trial is to investigate the prophylactic effects and safety of intravenous melatonin administered intraoperatively for prevention of postopreative agitation and emergence delirium in children after an elective surgical procedure. The study is designed as a randomised, double-blind, placebo-controlled clinical trial.

Nebulized Dexmedetomidine for Post-Anesthesia Delirium in Preschool Children

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.

Quantitative Neurofeedback Techniques for Treating Perioperative Cognitive Disorders in Elderly Patients

The goal of this clinical trial is to learn if quantitative measurement of brain and neurofeedback intervention techniques works to prevent perioperative neurocognitive deficits in elderly oncology patients who are to undergo elective major surgery. The main questions it aims to answer are: * Can neurofeedback intervention training reduce the incidence of postoperative delirium in elderly oncology patients? Researchers will compare the incidence of postoperative delirium in elderly oncology patients after training in neurofeedback intervention with those after living a normal life, to see if training in neurofeedback intervention before surgery is effective in preventing the development of postoperative delirium. Participants will: * Take neurocognitive feedback intervention training for 14 days prior to surgery (recommended to be used for at least 1 hour per day for a cumulative preoperative use of 14 hours). * Received preoperative and postoperative assessments of cognitive function by a third-party researcher, as well as daily delirium assessments for 7 days postoperatively. * The subjects in the control group lived a normal life every day before the operation, and the rest of the measures were the same as those in the intervention group.

Low Flow Anesthesia in Children Undergoing Strabismus Surgery

Emergence agitation (EA) involves restlessness, disorientation, excitation, non-purposeful movement, inconsolability, thrashing, and incoherence during early recovery from general anesthesia. Sevoflurane and desflurane have increased the incidence of EA in children. A proposed explanation for this is that sevoflurane and desflurane cause differential recovery rates in brain function, due to differences in clearance of inhalational anesthetics from the central nervous system; whereas audition and locomotion recover first, cognitive function recovers later, resulting in EA. Low-flow anaesthesia (LFA) occurs when the fresh gas flow (FGF) is significantly lower than the patient's minute volume. In a low-flow system, the recirculated fraction should amount to at least 50% after carbon dioxide (CO2) absorption.In LFA using minimal FGF (250-500 mL/min), if the vaporizer is turned off 10-15 minutes before the end of the operation and the FGF is not changed, the inhaled anesthetic agent concentration gradually and slowly decreases to zero and the inhaled agent consumption decreases even more. In a study conducted on infants undergoing cleft lip-palate surgery, it was shown that the incidence of postoperative agitation were statistically lower in infants who administered 0.5 L/min FGF. Strabismus surgery is one of the most frequently performed ophthalmologic operations in children and is associated with moderate postoperative pain and a high incidence of EA (40-86%). The incidence of EA after strabismus surgery is high, especially due to visual disturbances; however, the pathogenesis of this condition remains unclear. In our study, the effects of different FGFs administered in children undergoing strabismus surgery on EA and anesthetic agent consumption will be investigated.

Ketofol Versus Dexmedetomidine for Prevention of Emergence Delirium in Pediatric Patients Undergoing Squint Surgeries

The aim of the study is to compare the effectiveness of ketofol for the prevention of emergence delirium in pediatric patients undergoing squint surgery, in comparison to dexmedetomidine.

Frontal Alpha Asymmetry and Pediatric Emergence Delirium

This study aimed to investigate whether the association between the preoperative anxiety level and emergence delirium involves EEG frontal alpha asymmetry in pediatric patients undergoing ophthalmic surgery under general anesthesia. The investigators hypothesized that EEG frontal alpha asymmetry contributes a significant portion of the preoperative anxiety - emergence delirium association in pediatric patients. Mediation analysis will be performed to estimate the relationships between preoperative anxiety of children (modified Yale Preoperative Anxiety Scale (mYPAS)), EEG frontal alpha asymmetry, and emergence delirium (Pediatric Assessment of Emergence Delirium (PAED) scale).

Temperature Management on Postoperative Delirium

Presently, the effects of perioperative temperature management on postoperative delirium remain ambiguous. This study endeavors to explore the influence of intraoperative temperature variations in elderly hip fracture patients on postoperative delirium.

The PREVENT AGITATION Trial II - Children ≤1 Year

Emergence agitation is a clinical condition in which the child experiences a variety of behavioural disturbances including crying, thrashing, and disorientation during early awakening from anaesthesia. Emergence agitation is a common challenge in children with a reported incidence of approximately 25% ranging from 10 to 80 %. Clonidine is often used off-label in paediatric anaesthesia e.g. sedation in the intensive care unit, prevention of withdrawal symptoms after long-term sedation, as premedication before induction of anaesthesia or as treatment/prevention of emergence agitation. The study is designed as a randomised, placebo-controlled clinical trial evaluating efficacy and safety of a single dose of intraoperative clonidine in children 3-12 months, including pharmacokinetics.