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Agitation clinical trials

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NCT ID: NCT03317067 Completed - Delirium Clinical Trials

Effects of Dexmedetomidine on Delirium Duration of Non-intubated ICU Patients (4D Trial)

4D
Start date: December 21, 2017
Phase: Phase 3
Study type: Interventional

The primary purpose of the study is to evaluate whether dexmedetomidine is effective in treating agitated delirium of non-intubated ICI patients

NCT ID: NCT02863081 Completed - Pain Clinical Trials

Helping Older Persons Emerge Stronger

HOPES
Start date: July 2016
Phase: N/A
Study type: Observational

Select Specialty, a national network of more than 100 LTACHs across the United States, has expressed the desire to adopt the ABCDEF bundle as a "standard of care" for its patients. As part of this initiative, Select first plans to conduct an ABCDEF bundle quality improvement project in one of its local hospitals. The overall purpose of this before-after study is to study prospectively the process and effects of implementing the ABCDEF bundle into the everyday care of patients requiring prolonged mechanical ventilation in the LTACH setting.

NCT ID: NCT02848963 Completed - Postoperative Pain Clinical Trials

Comparison of Ketamine-propofol Combinations

Start date: July 2016
Phase: Phase 4
Study type: Interventional

ASA I-II 3-12 years old children participated to this study. All Participants will divide into the three groups. In Groups I, 2,5 mg/kg propofol and 0,5 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 5/1 ratio of ketamine-propofol mixture with %67 of Mcfarlan dose regiment. In Groups II, 2,75 mg/kg propofol and 0,41 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 6,7/1 ratio of ketamine-propofol mixture with %80 of Mcfarlan dose regiment. In Groups III, 3 mg/kg propofol and 0,3 mg/kg ketamine will apply at anaesthesia induction. General anaesthesia will be performed with 10/1 ratio of ketamine-propofol mixture with %90 of Mcfarlan dose regiment. After than surgical operation recovery time, PAED scores, FLACC scores, Staying time in PACU will be recorded. These data will be evaluated with statistically.

NCT ID: NCT02720705 Completed - Agitation Clinical Trials

Transbucal Dexmedetomidine for Prevention of Sevoflurane Emergence Agitation in Pre-school Children

Start date: May 2016
Phase: Phase 2/Phase 3
Study type: Interventional

The aim of this study is to evaluate the efficacy of transbucal dexmedetomidine given in preschool children undergoing tonsillectomy operations in the prevention sevoflurane agitation.

NCT ID: NCT02525991 Completed - Agitation Clinical Trials

Phase IV to Evaluate the Safety of Self-administered ADASUVE® in Agitated Patients Outside the Hospital Setting

Start date: September 8, 2016
Phase: Phase 4
Study type: Interventional

Phase IV, multinational, multicentre, open-label, non-randomized, clinical trial conducted in Europe (Spain, Germany, Finland, Norway, Romania and Austria) to evaluate the safety profile of ADASUVE® in agitated patients with schizophrenia or bipolar disorder when self-administered outside of a hospital setting without the supervision of a healthcare professional. The Study will aim to include approximately 500 patients who have been previously treated with ADASUVE® in the last 6 months prior to screening or recently treated during the planned recruitment period of 6 months with a 'positive outcome' ('ADASUVE® responder') according to Clinical Global Impressions (CGI-I) scale, from a total of about 30-34 centers. All patients will be followed up for a maximum of 6 months from baseline, during which it is expected that a new episode of agitation will occur.

NCT ID: NCT02428283 Completed - Agitation Clinical Trials

Scalp Nerve Block on Emergence Agitation

Start date: May 2015
Phase: Phase 4
Study type: Interventional

Emergence agitation is a common problem in children during recovery from sevoflurane anesthesia. Pain is considered as a cause of postoperative emergence agitation and compounding factor of agitation assessment in children. The purpose of this study was to investigate the effect of scalp nerve block on the emergence agitation in children undergoing nevus surgery during sevoflurane anesthesia.

NCT ID: NCT02351882 Completed - Pain Clinical Trials

Safety and Efficacy of Nabilone in Alzheimer's Disease

Start date: January 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Alzheimer's disease (AD) is commonly associated with behavioural changes such as agitation. Severe agitation is important to treat because it not only increases progression of AD and physical health problems (increased falls and weight loss), but it also decreases quality of life and increases caregiver stress. Currently prescribed treatments (i.e., antipsychotics) for agitation in AD do not work in everybody and when they do work the effect is small and they increase the risk of harmful side effects, including death. As a result, there is an urgent need for safer medication options. The cannabinoid nabilone can now be prescribed in capsule form for appetite and pain killing effects. Nabilone's calming effects may benefit those with agitation, and help the weight loss and untreated pain frequently associated with agitation. Through a clinical trial, the investigators hope identify the benefits of nabilone in the treatment of agitation in AD. The investigators objective is to determine whether nabilone is an efficacious and safe treatment for agitation, as well as having benefits for pain, weight and behavioural symptoms. This will be a 14 week clinical trial (participants take nabilone for 6 weeks, placebo for 6 weeks (order randomized) with 1 week between treatments). The investigators will assess and compare agitation, weight, pain, memory, behaviour and safety. Nabilone is a new class of medication that may be a safe and effective treatment for agitation in AD, with added benefits on appetite and pain. Reducing these symptoms would increase quality-of-life and reduce caregiver stress.

NCT ID: NCT02203019 Completed - Sepsis Clinical Trials

Study of Sedative Medications in Patients With Severe Infection and Respiratory Failure

PRO-DEFENSE
Start date: August 2014
Phase: Phase 4
Study type: Interventional

Patients with infections in their blood often become very sick. These patients are usually put in an intensive care unit for careful observation and treatment. These patients may develop a low blood pressure, lung failure, and kidney failure. When these problems develop, care becomes quite complicated. Patients with lung failure often need help with a breathing machine to make certain that the breathing is adequate. The machine helps keep the oxygen level high enough for healthy tissues. When patients are placed on the machine for breathing they require a tube to be placed into lungs. This can be quite uncomfortable. These patients need sedation to help them tolerate the uncomfortable breathing tube and other parts of their routine necessary care. This study will compare two drugs (dexmedetomidine and propofol) which are frequently used for sedation in intensive care patients. Clinical studies suggest that these drugs are both effective and safe. The main question is whether or not one of the drugs is better in a patient with a blood infection. This study will try to determine that. Our main goal is to see whether or not patients on one particular drug come off the breathing machine faster than patients on the other drug. These drugs are not experimental drugs and are approved by the Food and Drug Administration. There is no placebo drug being used in this study. All patients in this study will receive the best possible care based on their medical condition.

NCT ID: NCT02199262 Completed - Agitation Clinical Trials

Quality Improving Program on Agitation in the Surgical Intensive Care Unit

Start date: February 2004
Phase: N/A
Study type: Interventional

Agitation in the intensive care unit can have multiple consequences. The investigators hypothesize that agitation and its consequences can be reduced by the introduction of a reminder aiming at guiding the management of agitation. The investigators also hypothesize that they can prevent agitation and its consequences by acting on patients environment with reafferentation and relaxation methods. The investigators' objectives are to test within a quality improvement project by a prospective randomized study: - If by reducing the number of agitation episodes we reduce the number of harmful consequences. - If the introduction of reafferentation and relaxation methods (music therapy or reflexology) can prevent the occurrence of agitation. - If the introduction of a reminder on management of agitation can reduce the number of agitation episodes. This study is conducted in an18 general surgical ICU beds receiving 1600 patients / year for a total of 6900 hospital /days /year, in a tertiary teaching hospital. The study is organized in 3 phases: 1. First phase: Baseline phase (Prospective analysis of the present situation) 2. Second phase: Learning phase (Implementation of a reminder about the management of agitation and delirium ) 3. Third phase: Randomized Intervention (reminder alone vs addition of music or reflexology) The interventions are : 1. Implementation of a reminder of guidelines of agitation diagnosis and management. 2. Music intervention( see description below) + reminder 3. Reflexology (see description below)+ reminder Agitation is monitored with two scales SAS and CAM-ICU(description below) . Harmful consequences and complications are systematically registered as well as medication and the use of contention methods. Adherence to the implemented monitoring and interventions is also regularly checked. Data are daily collected (see details below) Statistical analysis and power calculation (see below)

NCT ID: NCT02194036 Completed - Depression Clinical Trials

Learning Oriented Physiotherapy - a New Approach

LOF
Start date: August 2014
Phase: N/A
Study type: Interventional

Outpatients that suffer from different anxiety disorders may have physical ailments that negatively affect daily life functioning and quality of life. LOF is a physical therapy approach focusing on the link between bodily and mental balance and through defined, but simple movements, patients are expected to learn how to cope and reduce health complaints. This study aims to investigate the short- and longterm effect of LOF compared to other standardized psychiatric treatments given in the clinic on levels of anxiety and depression, health related function and quality of life.