View clinical trials related to Psychomotor Agitation.
Filter by:Phase 3 safety and efficacy study of Staccato Loxapine in the treatment of acute agitation in schizophrenic or bipolar disorder patients.
Suvorexant improves sleep latency and wake after sleep onset in patients with primary insomnia, and is FDA approved for this condition. However, no data exist on its effects in RLS, so far. The investigators consider that suvorexant might provide a stable therapeutic efficacy for the long treatment, avoiding the risk of augmentation of symptoms commonly seen under dopamine agonists.
Emergence agitation (EA) is a dissociated state of consciousness in which the child is inconsolable, irritable, uncooperative, typically thrashing, crying, moaning, or incoherent. Although usually transient, it is not only an extremely distressing event for children, parents, and staff, but may also result in self-injury or the need for restraint. The prevalence in children appears to be between 10% and 80% depending upon the definition and measurement tools used and is more frequently observed in the pre-school age-group. A clear correlation has been found between EA and negative postoperative behavioral changes, including anxiety, eating and sleeping disorders, enuresis, fear of darkness, that may persist for an extended period of time affecting emotional and cognitive development.Currently, numerous interventions have been studied to manage EA after surgery. Among them, dexmedetomidine (DEX) as a kind of highly selective α2 adrenergic receptor agonist has been done to reduce EA in children. Unfortunately, no studies examined posthospitalization negative behaviour changes.
Central venous lines insertion are common procedures these days. CVL placed under USG guidance have high success rates and low complications even in developing country settings. However, the investigators still have to rely on chest x-ray (CXR) to confirm the correct placement of central venous lines as a gold standard method. This might be time consuming and may cause delay in initiation of treatment. In some cases, as in operating room, the treatment is started even before confirmation by CXR. Ultrasound has ability to localize the tip of the catheter at the superior venacava- right atrium junction using agitated saline and the appearance of contrast within 2 seconds in right atrium. However, this technique is rarely used. The investigators, therefore, designed the trial to study whether confirmation of tip of CVL by ultrasound is non-inferior to the CXR confirmation.
Compare the effects of pharmacologic and nonpharmacologic premedications on postoperative emergence delirium and preoperative anxiety, vital parameters, blood pressure, heart rate, SpO2, and pain at PACU 15 minutes after adenotonsillectomy .
1. The title of this study is a multi-center,non randomized,open-labeled,intervention study:the efficacy and safety of intramuscular ziprasidone for three days in patients with acute psychotic agitation. 2. The primary objectiveis to evaluate the efficacy of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice. 3. The secondary objectives are:1.To evaluate the safety of intramuscular ziprasidone in patients with acute psychotic agitation in daily clinical practice.2.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with agitation in the different psychotic disorder 3.To compare the efficacy and tolerance of intramuscular ziprasidone in patients with first episode andmulti-episode patients. 4.To explore the measured based administration according to severity of symptoms.5.To compare the efficacy and tolerance of ziprasidone im between the monotherapy and combination with other antipsychotic drug in clinical practice. 4. The Rationale:In China, the studies of ziprasidone im treating agitation focus on schizophrenia. But in the foreign country, ziprasidone im also is approved to treat psychotic agitation, including bipolar and schizoaffective disorder. And in the clinical practice of China, ziprasidone im is also used to treat other patients, although the evidence is less. In this study, we assume ziprasidone im treat the psychotic agitation is effective and safe. 5. Study populations:The study plan to enroll 1000 subjects in China. （6）The background and the hypothesis：The researches of ziprasidone mesylate injection in our country are more concentrated in schizophrenia at present, while in foreign countries ziprasidone is approved for psychotic agitation, including mania etc. It's also used for substance abuse and alcohol induced agitation.Therefore, this study assumes that ziprasidone mesylate injection is effective in the treatment of acute agitation, and it's well tolerated.
This is a phase IV single-blind, placebo run-in fixed dose single-group study to assess objective and subjective effects of GEn on sleep EEG, BP, and anterior tibialis EMG responsivity in patients with RLS. The study will include 8 visits over a period of up to 8 weeks for eligible subjects including a 1 to 3-week Screening/Washout Period, a 1-week placebo run-in period, and a 4-week Treatment Period.The first placebo dose will be administered within 1 to 3 weeks after Screening/Washout. The total duration of the study from the first subject enrolled to the last subject completed will be approximately 1 year.
Restless Legs Syndrome (RLS) is a sensorimotor disorder that syndrome may substantially interfere with normal sleep, leading to significant impairment in patients' productivity and quality of life. The most common and potent of all treatment regimens are the dopaminergic agonist agents, which carry serious adverse events in their prolonged use despite their augmentation. A few basic studies have suggested a potential relationship between vitamin D and RLS. It has been implicated that dopaminergic system dysfunction plays a role in the development of RLS, while vitamin D has a protective effect on that system. This has been further substantiated by few clinical observations that showed prompt improvement of RLS patients upon receiving dopaminergic agents such as carbamazepine. Other studies have revealed low serum levels of vitamin D in RLS patients, along with remarkable improvement after vitamin D replacement therapy, as has been demonstrated in a recent pilot study. This collectively points at vitamin D as a potential, more natural and safer treatment option for those suffering from RLS. However, the role of vitamin D in RLS has not been effectively investigated. The aim of this 12-week, triple-blinded, randomized, placebo-controlled trial is to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions that the results will contribute to better understanding of the disease and its management. Methods and Materials: This 12-week, double-blinded, randomized, placebo-controlled trial is take place over a duration of 2 years. It will be held in the city of Jeddah to assess a sample of Saudi residents of the Western region. It is comprised of a number of visits, with the first one consisting of a questionnaire that is to be answered regarding RLS, physical examination, electromyography, the objective multiple Suggested Immobilization test, and blood tests. The main purpose of the second visit is to establish a diagnosis of RLS. Clinic visits number 3 through 6 comprise the pre-randomizaiton phase. Their purpose is to determine the patient's adherence to trial procedures and pharmacological treatment. Then, patients are to visit the clinic every two weeks for the first two months, then at week 12. Patients will be assessed in regards to treatment response and adverse effects through history and physical examination along with further blood tests. Aim: to confirm the relationship between vitamin D deficiency and RLS and hence elucidate the efficacy of vitamin D replacement therapy in reducing the severity of RLS, with predictions that the results will contribute to better understanding of the disease and its management.
To compare the effect of two different agents deksmedetomidine, remifentanil and placebo, agitation and recovery condition, on nasal septum operation.
The purpose of this study is to determine whether the compound lidocaine cream is effective in preventing postoperative agitation in patients with endotracheal intubation for general anesthesia.