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NCT04516057
This study will look at whether nabilone is an effective treatment for agitation in Alzheimer's disease (AD) patients. Agitation is highly prevalent in patients with AD and is one of the most distressing and challenging-to-treat symptoms. Agitation is associated with faster progression to institutionalization, increased caregiver burden, poorer quality of life, and increased risk of death. In addition, current pharmacological options show only modest efficacy and elevated risks of adverse events. Therefore, identifying safer and more effective treatments for agitation in AD is a clinical and research priority. Nabilone is a synthetic cannabinoid that is Health Canada-approved to treat chemotherapy-induced nausea and vomiting. The PI's research group completed a 6-week double-blind placebo-controlled randomized cross-over pilot trial in 38 patients with moderate-to-severe AD, providing the first preliminary evidence regarding the safety and efficacy of nabilone in this population. They found that nabilone significantly improved agitation, overall neuropsychiatric symptoms, and caregiver distress. That study was limited by its sample size and questions remain regarding the efficacy of nabilone for nutrition and pain and predictors of response. However, the promising preliminary findings encourage a pivotal, practice-changing phase III trial to inform clinical practice. Participants in this study will be randomized to receive either nabilone or a placebo for 8 weeks. In addition to looking at the effectiveness of nabilone in treating agitation, the researchers will also look at whether it is beneficial for other relevant outcomes for patients with AD including overall neuropsychiatric symptoms, caregiver distress, cognition, nutritional status, and pain. Participants will also be followed for 8 weeks following completion of the study treatment.
NCT06808984
This is a study to evaluate the efficacy, safety, and tolerability of BMS-986368, a FAAH/MAGL inhibitor, for the treatment of agitation in participants with Alzheimer's Disease.
NCT07139847
This randomized, double-blind, controlled trial investigates the effect of intraoperative magnesium sulfate infusion on the incidence of postoperative emergence agitation in adult patients undergoing elective lumbar microdiscectomy under general anesthesia. Eligible participants (ASA physical status I-II, aged 18-70 years) will be randomly assigned to receive either magnesium sulfate or 0.9% saline during surgery. The primary outcome is the incidence of emergence agitation in the post-anesthesia care unit (PACU), assessed at admission and at 5, 10, 15, and 30 minutes using the Ramsay Sedation Scale. Secondary outcomes include postoperative pain scores (Numeric Rating Scale), intraoperative remifentanil consumption, recovery and extubation times, tramadol use in the PACU, and any adverse events related to magnesium infusion.
NCT07253428
The impact of sugammadex on agitation upon emergence following adult nasal surgeries is an issue which needs to be studied that links anesthetic management with postoperative recovery.
NCT07243990
Postoperative agitation is frequently observed in the pediatric patient group following general anesthesia. The exact cause of this agitation has not been clearly determined; however, it may be associated with various factors such as anesthesia depth, family approach, postoperative pain, or unpleasant odors perceived by the child. The depth of anesthesia is indirectly monitored by observing the patient's blood pressure, heart rate, and oxygen saturation, as well as by assessing the alveolar concentration of the inhalation agent. Patients under anesthesia are in a state of deep sleep. In recent years, this sleep state has begun to be monitored more closely with the development of new devices. Electroencephalography (EEG) is a test that records and measures the brain's electrical activity, providing information about the depth of sleep according to the patient's brain activity. The Density Spectral Array (DSA) device, developed for use in operating rooms, facilitates the interpretation of EEG data and guides the anesthesiologist. In our operating room, patients under anesthesia are also monitored using this device. Our aim is to evaluate emergence agitation in patients monitored with this device compared to those who are not monitored.
NCT02446132
This was an extension study of the Phase 3 Studies 15-AVP-786-301, 15-AVP-786-302, and 17-AVP-786-305.
NCT06665672
The overarching goal of this research study is to determine "proof of concept" of effect of a non-invasive sleep aid device on sleep and performance during sleep opportunities (naps) that occur during and after simulated night shift work. Aim 1: To determine the effect of the ApolloNeuro device on sleep duration, sleep architecture, blood pressure, heart rate variability, and subjective ratings of sleep quality during and after simulated night shift work. Aim 2: To determine the effect of the ApolloNeuro device on post-sleep psychomotor performance.
NCT05658510
In this study, an investigational medication named BXCL501 is being tested for the treatment of episodes of agitation associated with bipolar I and bipolar II disorder, schizophrenia, schizoaffective and schizophreniform disorder. This study compares the study drug to a placebo.
NCT07165899
This study aims to explore the potential of binaural beats, adjusted in real-time via EEG feedback, to positively influence brain states related to relaxation, focus, and cognitive performance. The investigators are examining how these auditory techniques can improve memory, attention, and overall subjective well-being.
NCT06648122
This study was planned as a prospective, observational study. The study will include pediatric patients aged 3-12 who will undergo surgery. Our hypothesis is that haemogram parameters, which are a simple, cheap and accessible method, and the inflammatory markers we obtain from them are associated with preoperative anxiety and emergence delirium
NCT05522647
There is a risk of falls and injuries in bedridden hospitalized patients, increased in agitated or confused patients. In neurosurgery departments, brain damaged patients can present a loss of consciousness of risky behaviors and be in a state of agitation which frequently leads to their endangerment. The repercussions of this endangerment are multiple. For the patients, there may be a feeling of insecurity, with physical or chemical restraint solutions which deprive them of their freedom without a total guarantee of safety. For the caregivers, there is an emotional distress in front of this endangerment, and a professional guilt. Finally, there are economic repercussions due to the costs of complementary examinations and the lengthening of hospitalization. The objective of the present study is to determine the nature and frequency of occurrence of risk behaviours, through the observation of bedridden and agitated hospitalized patients. These risk behaviours are defined as potentially dangerous and are warning signs for the caregiver. A better understanding of these behaviours could help to better anticipate falls and injuries and to implement preventive measures more quickly.
NCT06993194
Traumatic brain injury is a serious and common medical condition that often requires admission to the intensive care unit and the use of mechanical ventilation. One of the most frequent and challenging complications in these patients is the development of delirium and agitation. These symptoms can prolong hospitalization, increase the risk of further brain injury, and complicate the medical and nursing care of the patient. This interventional clinical trial is designed to compare the effects of two medications-haloperidol and dexmedetomidine-on the management of delirium and agitation in patients with traumatic brain injury admitted to the intensive care unit. Haloperidol is a traditional antipsychotic medication that is commonly used to manage agitation, but it may cause undesirable side effects such as movement disorders and disturbances in heart rhythm. Dexmedetomidine is a medication that acts on specific receptors in the nervous system to produce sedation and reduce agitation, and it is believed to cause fewer side effects related to breathing and movement. The study will include forty adult patients with confirmed traumatic brain injury. These patients will be randomly assigned to receive either haloperidol or dexmedetomidine according to standard dosing guidelines. The study will evaluate and compare the following outcomes in both treatment groups: the presence and severity of delirium, the level of agitation, the total number of days the patient requires mechanical ventilation, the length of stay in the intensive care unit, the need for additional sedative medications, and the occurrence of any harmful effects from the study drugs. To measure these outcomes, patients will be monitored using standardized tools that assess consciousness, agitation levels, and the presence of confusion. Additional medical examinations and laboratory tests will be conducted to ensure patient safety and collect relevant clinical data. This study will be carried out in accordance with the ethical guidelines outlined in the Declaration of Helsinki and will follow internationally accepted standards for research involving human participants. Approval has been granted by the appropriate medical ethics committee at the Faculty of Medicine, Benha University. Informed consent will be obtained from all patients or their legal representatives before participation. The purpose of this research is to provide scientific evidence that can help doctors choose the most appropriate and safe medication for managing delirium and agitation in patients with traumatic brain injury who are being treated in the intensive care unit.
NCT06887998
Emergence agitation is a postanesthetic phenomenon that develops in the early phase of recovery from general anesthesia, and is characterized by agitation, disorientation, confusion, and possible violent behavior. Emergence agitation can cause serious events such as self-extubation, bleeding, catheter removal and even falling out of the bed leading to severe injuries . Furthermore, it may lead to injuries to health care providers and increase the demand on human resources. While its pathogenesis remains unclear, previous studies reported that ENT (ear, nose, and throat) surgical procedures have a higher incidence of emergence agitation in both adults and children. Emergence agitation is a common phenomenon occurring in 22.2% in adult patients undergoing general anesthesia for nasal surgery . Gabapentin, agamma-aminobutyricacidanalog, binds the voltage-gated calcium channels of the dorsal root ganglion, at α2-δ subunite. Gabapentin binding to these channels reduces the release of excitatory neurotransmitters preventing the propagation of painful stimuli which makes its use helpful in treatment of postoperative pain and agitation with less side effects compared with benzodiazepines and opioids . Gabapentin has been used in controlling acute perioperative conditions like preoperative anxiety, intraoperative attenuation of hemodynamic response to noxious stimuli and post operative pain, delirium and nausea and vomiting. A previous study examined the effect of oral gabapentin 600 mg in reducing emergence agitation in adult patients undergowing rhinoplasty, but this study will examine the effect of two different doses of oral gabapentin 400 mg and 600 mg in reducing emergence agitation after nasal surgery.
NCT06752616
The purpose of the study is to improve the pharmacological treatment of psychiatric patients with acute agitation.
NCT03393520
This study will be conducted to evaluate the efficacy, safety, and tolerability of AVP-786 compared to placebo, for the treatment of agitation in participants with dementia of the Alzheimer's type.
NCT06571890
Emergence agitation is a significant and persistent challenge in paediatric anaesthesia, especially in children of preschool age. In this study, the investigators examined whether anaesthesia titration with either a sleep depth monitor or a pain monitor would result in changed postoperative agitation rates, measured via the Richmond Agitation and Sedation Score (RASS). 93 children participated. The participants were divided into three groups: A conventional anaesthesia group, an EEG (Electroencephalography)- monitored and a pain-monitored group. The pain-monitored children received the most pain medication but were discharged at the same rate as the other children with unchanged rates of nausea and vomiting and less agitation than the sleep-monitored children.
NCT05612711
The goal of this clinical trial is to study the effects of dronabinol in US Veterans with agitation related to moderate to severe dementia. The main goals of the study are: * To evaluate the efficacy of dronabinol for the treatment of agitation in moderate to severe dementia compared to placebo * To evaluate the safety of dronabinol in the treatment of agitation in moderate to severe dementia compared to placebo Fifty (50) subjects will be given either dronabinol or placebo for 8 weeks. All subjects will then undergo a "washout" phase for 3 weeks, followed by the crossover intervention (i.e. subjects who received placebo during the first phase will receive dronabinol during the second phase, and vice versa). Thus, all participants will be taking dronabinol at some point during the study. During the study, subjects will undergo evaluations for: * Agitation * Cognitive changes * Physical changes (i.e. labs, ekg, physical exam)
NCT04797715
This is a multi-center, double-blind, placebo-controlled, randomized withdrawal study to evaluate the efficacy and safety of AXS-05 compared to placebo in the treatment of agitation symptoms in subjects with agitation associated with Alzheimer's disease.
NCT04350424
This is a prospective cohort study that will analyze psychomotoric recovery using a commercially available driving simulator following sedation for endoscopic procedures in subjects undergoing elective outpatient endoscopic procedures. Patients receiving both propofol based sedation and well as those receiving a combination of fentanyl and midazolam will be studied. Baseline data will be obtained after training on the simulator. Following the procedure and after meeting standard discharge criteria, the subjects will undergo the same driving simulation to ascertain psychomotoric recovery.
NCT05641376
Pediatric patients undergoing tonsillectomy and adenoidectomy usually have a high incidence of postoperative EA, which increases the risk of developing postoperative airway obstruction and respiratory depression due to anatomical characteristics of operative location and increased susceptibility to opioid analgesics. the study will compare between nebulized and intravenous bolus of dexmedetomidine as a prophylaxis against postanesthetic emergence agitation in children undergoing tonsillectomy, adenoidectomy or adeno-tonsillectomy procedures.