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Showing 1-20 of 122 trials
NCT07139847
In this retrospective study, the effect of intraoperative magnesium sulfate infusion on the incidence of postoperative emergence agitation was evaluated in adult patients who underwent elective lumbar microdiscectomy under general anesthesia. The medical records of patients aged 18-70 years with an ASA physical status of I-II were retrospectively reviewed. Patients were evaluated according to whether they received intraoperative magnesium sulfate infusion as part of anesthetic management. The primary outcome measure was the incidence of emergence agitation in the post-anesthesia care unit; this assessment was based on Ramsay Sedation Scale scores recorded in the post-anesthesia care unit at admission and at 5, 10, 15, and 30 minutes. Secondary outcome measures included postoperative pain scores assessed using the Numeric Rating Scale, intraoperative remifentanil consumption, recovery and extubation times, tramadol requirement in the post-anesthesia care unit, and possible adverse events related to magnesium infusion.
NCT06937229
The purpose of this study is to evaluate the long-term efficacy and safety of combined formulation of xanomeline tartrate/trospium chloride in an immediate release (IR) capsule (KarXT) and xanomeline enteric capsules (KarX-EC) in participants with agitation associated with Alzheimer's Disease who completed the parent studies CN012-0023 or CN012-0024.
NCT07645521
This randomized double-blind controlled trial aims to evaluate whether bilateral trans-nasal sphenopalatine ganglion block (SPGB) using bupivacaine reduces the incidence of emergence agitation following Functional Endoscopic Sinus Surgery (FESS) compared with placebo. Secondary objectives include evaluation of postoperative pain, postoperative opioid consumption, hemodynamic parameters, postoperative nausea and vomiting, and adverse events.
NCT04276883
This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in bipolar disorder. The BXCL501-302 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with bipolar disorder.
NCT07302815
This prospective randomized controlled study will be conducted to evaluate the effect of preoperative single, micro-dose of dexmedetomidine (0.3μg/kg) on the incidence and severity of EA in adults undergoing Septoplasty surgeries
NCT07552259
This study aims to evaluate the effect of preoperative fasting duration on postoperative pain and emergence agitation in pediatric patients undergoing urogenital surgery.
NCT07026890
Psychomotor Disadaptation Syndrome (PMDS) is characterised by a deterioration in postural function, gait and psychomotor automatisms in the elderly. It is often associated with falls and can manifest itself as retropulsion, gait abnormalities, neurological disorders and psycho-behavioural problems. For the majority of these patients, a stay in a geriatric medical and rehabilitation centre is necessary, enabling an objective assessment of these disorders and multi-professional care, including physiotherapists, occupational therapists and adapted physical activity teachers, aimed at restoring safe movement and motor independence. However, rehabilitation relies on traditional exercises that are limited, repetitive and sometimes far removed from everyday activities. Technological innovations such as virtual reality (VR) offer opportunities to improve care by creating immersive environments that reproduce real-life situations. VR could thus help to rehabilitate the motor problems associated with MS. The aim of the VIR-AGE project is to study the clinical benefits of VR in the rehabilitation of hospitalised elderly people suffering from PMDS in terms of functional deficits, particularly motor deficits. The study will take place at the Centre gériatrique Champmaillot of the CHU Dijon Bourgogne. A total of 50 patients with SPDM will take part. The total duration of your participation is 5 weeks.
NCT07536568
This study aims to evaluate the efficacy of sublingual caffeine in reducing recovery time and incidence of postoperative agitation in elderly patients undergoing general anesthesia.
NCT07534956
Emergence delirium is a common complication in pediatric patients undergoing general anesthesia. The aim of this study is to investigate the incidence of postoperative awakening delirium and agitation in pediatric patients aged 3-10 years (ASA I-II) using two different target-controlled infusion (TCI) methods (Paedfusor and Eleveld) for TIVA, compared to inhalation anesthesia. This study will examine the effect of two different TCI models on postoperative awakening agitation/delirium by comparing them with each other and with inhalation anesthesia.
NCT04075435
This is an open label, eight week, clinical trial of a proprietary high CBD/low THC sublingual solution for the treatment of clinically significant anxiety and agitation in individuals with mild cognitive impairment (MCI) or mild to moderate Alzheimer's Disease (AD).
NCT07486427
Investigation of the effect of preoperative parental anxiety and sociodemographic characteristics on emergence agitation in patients undergoing pediatric adenotonsil surgery
NCT06884735
According to demographic projections, by 2040, a quarter of the French population will be over 65. In this age group, the quality and quantity of visual, somaesthetic and vestibular information decline. This weakening of the balancing and the recurrence of falls lead to a restriction of activities of daily living and give rise to a fear of falling. Psychomotor maladjustment syndrome (PMDS) is a serious consequence of falls. A significant retropulsion when sitting or standing, as well as hypertonia characterize the posturobehavioral component of PMDS. It coexists with a psychological component, marked by a fear of the anterior emptiness. A series of studies inducing fear and experimentally manipulating its intensity demonstrated a greater displacement of the center of pressure when subjects were exposed to elevated platforms. In addition to the subjective evaluation of fear, this emotion can be assessed by heart rate variability. Despite the existence of standards and metrics adapted to the clinical setting, only one study investigated the association between the number of falls and heart rate variability in patients with neurodegenerative disorders. In recent years, cognitive and behavioral therapies using virtual reality (TERV) have improved balance in patients with cardiovascular disease and Parkinson's disease. Virtual reality (VR) thus appears to be an interesting therapeutic approach to the treatment of psychological as well as postural-behavioral disorders of PDMS. Although the feasibility of a VR intervention has been tested in elderly people (APs) suffering from PMDS, its effect has never been evaluated.
NCT07422311
This study tests a medication called dronabinol in people with Alzheimer's disease. First, participants go through up to 4 weeks of screening. Then, over 2 weeks, the dose of the study drug is slowly increased. For the next 10 weeks, participants stay on either dronabinol or a placebo. After finishing this part of the study, participants can join a 6-month extension where everyone receives dronabinol. Those already on the drug stay on their same dose, while those who were on placebo gradually increase their dose over 2 weeks. All participants take dronabinol for the rest of the extension, then complete a final safety check 4 weeks after stopping the medication. Usual medical treatments are continued throughout the study.
NCT07394647
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.
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.
NCT07355049
The effect of intravenous dexmedetomidine versus intravenous lidocaine on the emergence agitation after endoscopic sinus surgery.
NCT06041646
This is an in-clinic, single arm, open-label study assessing tachyphylaxis, tolerance, and withdrawal following repeated doses of Igalmi in adult males and females with agitation associated with schizophrenia or bipolar disorder.
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.
NCT05557409
This trial is a multi-center, double-blind, placebo-controlled, randomized study to evaluate the efficacy and safety of AXS-05 compared to placebo for the treatment of agitation associated with Alzheimer's disease.