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Agitation clinical trials

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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: 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: 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.

NCT ID: NCT04266340 Completed - Agitation Clinical Trials

Different Premedication in Pediatric Patients

Start date: December 13, 2020
Phase: N/A
Study type: Interventional

The investigators studied the effects of intranasal dexmedetomidine compared with oral midazolam with different doses for premedication in children. One hundred and twenty children aged between 2 and 12 years were randomly allocated to one of four groups:2.5µg/kg intranasal dexmedetomidine group ; 0.5mg/kg oral midazolam group;0.05 mg/kg intravenous injection midazolam group; no premedication group. Sedation levels 10, 20, and 30min after premedication were evaluated using a 5-point sedation scale. A 4-point emotional state score was used to evaluate participators when they were separated from their parents and their response to intravenous cannulation or facemask application. Agitation scores (Pediatric Anesthe-sia Emergence Delirium [PAED] scale) and POV were assessed in the postanesthetic care unit (PACU).Times to endotracheal tube or laryngeal mask airway removal, discharge from the PACU and patients' satisfaction degree were also assessed.

NCT ID: NCT04010305 Completed - Schizophrenia Clinical Trials

Sub-Lingual Dexmedetomidine in Agitation Associated With Schizophrenia

Start date: May 22, 2019
Phase: Phase 1
Study type: Interventional

This is a two-stage adaptive Phase Ib trial design, that will identify two doses (lowest dose with clinical benefit and highest safe dose) in a first stage and better evaluate safety, tolerability and variability of effect in the second stage.

NCT ID: NCT03773874 Completed - Pain Clinical Trials

Assessment of Analgesia, Sedation, Physical Restraints and Delirium in Spanish Intensive Care Units

ASCyD
Start date: February 12, 2018
Phase:
Study type: Observational [Patient Registry]

This study assess which Spanish intensive care units evaluate and record, in a standardized way, levels of pain, sedation / agitation, use of physical restraints and prevalence of delirium. Also determine the use of validated assessment tools and explore levels of pain and sedation / agitation, use of physical restraints and prevalence of delirium.

NCT ID: NCT03639558 Completed - Aggression Clinical Trials

TREC-Lebanon: A Trial for Rapid Tranquilisation for Agitated Patients in the Emergency Setting

TREC
Start date: August 28, 2018
Phase: Phase 4
Study type: Interventional

This is a randomised controlled trial comparing haloperidol + promethazine versus haloperidol + promethazine + chlorpromazine for agitated patients in the emergency department.

NCT ID: NCT03554915 Completed - Agitation Clinical Trials

Ketamine Versus Midazolam for Prehospital Agitation

Start date: August 1, 2017
Phase:
Study type: Observational

This research study is being done to figure out the best approach to treatment of pre-hospital agitation. It will compare two tiered dosing treatment protocols, one ketamine-based and one midazolam-based. Agitation is a state of extreme emotional disturbance where patients can become physically aggressive or violent, endangering themselves and those who are caring for them. Often chemical substances or severe mental illness are involved in this level of agitation. Specifically, the investigators are interested in studying agitation that is treated in the prehospital setting by paramedics. This study's hypothesis is a ketamine-based protocol will achieve a faster time to adequate sedation than a midazolam-based protocol for treatment of agitation in the prehospital environment. This study will observe the natural history of an emergency medical services standard operating procedure change from a ketamine-based protocol to a midazolam-based protocol.