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Agitation clinical trials

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NCT ID: NCT05276830 Terminated - Dementia Clinical Trials

An Efficacy, and Safety Study Of BXCL501 For The Treatment Of Agitation Associated With Dementia

Start date: February 8, 2022
Phase: Phase 2
Study type: Interventional

A randomized, double-blind, placebo-controlled parallel group 3-arm study assessing efficacy, safety, and tolerability of two doses BXCL501 in male and female geriatric residents (65 years and older) with acute agitation associated with all forms of dementia (i.e., probably Alzheimer's Disease, vascular dementia; mixed; frontotemporal dementia) excluding Parkinson's-Related Dementia and Lewy Body Dementia.

NCT ID: NCT05273671 Recruiting - Agitation Clinical Trials

Nalbuphine Versus Dexmedetomidine for Prevention of Emergence Agitation in Pediatrics

Start date: March 1, 2022
Phase: Phase 4
Study type: Interventional

the investigators hypothesized that Nalbuphine may be alternative pharmacological agent for prevention of emergence agitation in pediatrics who will be scheduled for elective lower abdominal surgical procedures (inguinal hernia repair and hypospadias) during sevoflurane anesthesia

NCT ID: NCT05271552 Completed - Dementia Clinical Trials

Dexmedetomidine in the Treatment of Agitation Associated With Dementia (TRANQUILITY II)

Start date: April 27, 2022
Phase: Phase 3
Study type: Interventional

A study to determine the safety and efficacy of BXCL501 dosing for episodes of agitation associated with dementia when they occur (given as needed [PRN]), for a maximum of 28 doses within a 12-week treatment period.

NCT ID: NCT05165914 Completed - Agitation Clinical Trials

Midazolam Effect on Agitation Postnasal Surgery

Start date: May 27, 2021
Phase: N/A
Study type: Interventional

Postoperative agitation is a common complication, it's incidence post head and neck surgery is around 11-26%. Avoiding such complication is mandatory to facilitate patient's recovery and reduce risk of postoperative agitation related complications. Our study aims to detect the incidence of agitation following nasal surgery, and to determine the midazolam effect on agitation, when administered just before emergence from anesthesia.

NCT ID: NCT04950738 Not yet recruiting - Delirium Clinical Trials

The Effectiveness of Acupuncture for Complications in Critically Ill Patients

Start date: August 1, 2021
Phase: N/A
Study type: Interventional

Introduction: Intensive care unit (ICU) is a special department in the health care facility. Although with high development of modern medicine nowadays, the average mortality rate in ICU is still around 7 to 20 %. There are a few tricky problems that intensivists and ICU nurses faced very often, including ICU delirium, arrhythmia and poor digestion problem that will all affect the mortality and morbidity rate of critical care patients. Methods: A randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patients will have to meet the following criteria: age 20-90, newly ICU admission(<48 hours), APACHE score <30, one or no inotropic medicine use, FiO2< 60%. Three interventions will be given in each group. The main outcomes will be the incidence of arrhythmia, delirium, and poor digestion and the severity of pain. We will also record ICU mortality, ICU stays and hospital days.

NCT ID: NCT04908605 Completed - Agitation Clinical Trials

Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine

Start date: June 15, 2021
Phase: Phase 4
Study type: Interventional

Emergence agitation (EA) is common after nasal surgery under general anesthesia, which can lead to several problems, such as increased risk of injury to the patient or medical staff, pain, decreased patient satisfaction, hemorrhage, re-bleeding at the operation site and unplanned self-extubation. Melatonin is an oral or sublingual medication, most commonly used for insomnia and improving sleep in different conditions for example shift-work disorder and for helping people to establish a day and night cycle especially blind children or adults. Mirtazapine is an antidepressant used in medicine in a pill form, most commonly used for major depressive disorder and other mood disorders, relief of anxiety, panic disorders, insomnia, headache and migraine.

NCT ID: NCT04722614 Completed - Agitation Clinical Trials

Music and Essential Oil in Agitation

Start date: April 11, 2021
Phase: N/A
Study type: Interventional

The study aims to assess the effect of using music and essential oil on agitation in mechanically ventilated patients. Listening to classical relaxation music, and inhalation to bergamot oil will be used in this study.

NCT ID: NCT04516057 Recruiting - Alzheimer Disease Clinical Trials

Nabilone for Agitation Blinded Intervention Trial

NAB-IT
Start date: February 1, 2021
Phase: Phase 3
Study type: Interventional

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.

NCT ID: NCT04312893 Recruiting - Delirium Clinical Trials

The Effectiveness of Acupuncture for Delirium in Critically Ill Patients

Start date: March 12, 2020
Phase: N/A
Study type: Interventional

Introduction: Intensive care unit (ICU) delirium is an acute onset of brain dysfunction, which can affect 25-80% of ICU patients. Delirium is also associated with long term cognition impairment, higher mortality and higher ICU costs. Previous acupuncture studies showed the potential to prevent delirium. This study will examine the ability of acupuncture to treat ICU delirium. Methods: A double-blind randomized control trial will examine the effect of press tack acupuncture vs. press tack placebos. The patients will be randomly divided (1:1) into one of two groups. A total of 80 ICU patient will have to meet the following criteria: age 20-90, APACHE score <30, Intensive Care Delirium Screening Checklist (ICDSC) >4 points (indicates existing delirium), Richmond Agitation-Sedation Scale (RASS): +1, +2, +3, +4, -1, -2. Three interventions will be given in each group. The main outcomes will be the delirium days according to the ICDSC.

NCT ID: NCT04268303 Completed - Schizophrenia Clinical Trials

Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia

SERENITY I
Start date: January 24, 2020
Phase: Phase 3
Study type: Interventional

This is a definitive study to support the safety and efficacy evaluation of BXCL501 for the acute treatment of agitation in schizophrenia. The BXCL501-301 study is designed to characterize the efficacy, safety and tolerability of BXCL501 (sublingual film formulation of DEX, HCl) in agitation associated with schizophrenia, schizoaffective disorder or schizophreniform disorder.