Agitation,Psychomotor Clinical Trial
Official title:
PRevention of pAtient's agItation and Enhancement of Their SafEty (PRAISE): Improving Intensive Care Treatment Using a Multicomponent Pharmacological Intervention
Despite deleterious effects, physical restraints are still commonly used in (expected to become) agitated patients in Dutch ICUs (20-25%). This study aims to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints in (expected to become) agitated adult ICU patients.
Applying physical restraints (PR) has detrimental short- and long-term effects on patients and is increasingly seen as inhumane and outdated. Nonetheless, PR are still used in approximately 20-25% of all patients during their intensive care unit (ICU) stay in the Netherlands. The aim of this study is to determine the effectiveness of a person-centered multicomponent intervention (MCI) program consisting of non-pharmacological interventions combined with goal directed light sedation using dexmedetomidine compared to the old standard of care including physical restraints on short- and long-term outcomes and healthcare costs in (expected to become) agitated adult ICU patients. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03110900 -
Inhaled Loxapine vs Intramuscular (IM) Haloperidol + Lorazepam for Agitation
|
Phase 4 | |
| Completed |
NCT05272501 -
CAlming Touch for People With Agitation or Other Behavioural Symptoms of DEMentia - A Randomized Feasibility Trial
|
N/A | |
| Completed |
NCT06041646 -
Tachyphylaxis, Tolerance, & Withdrawal Post Treatment With Igalmi for Agitation in Schizophrenia or Bipolar Disorder
|
Phase 4 | |
| Completed |
NCT06217146 -
A Medical Cannabis Oil for Treatment of Agitation and Disruptive Behaviors in Subjects With Dementia.
|
N/A | |
| Recruiting |
NCT05543681 -
IGC-AD1 Trial on Agitation in Dementia Due to Alzheimer's
|
Phase 2 | |
| Recruiting |
NCT03513549 -
Observational Study Evaluating the Safety of ADASUVE® in Agitation Associated With Schizophrenia or Bipolar I Disorder
|
||
| Active, not recruiting |
NCT05658510 -
Dexmedetomidine in the Treatment of Agitation Associated With Schizophrenia and Bipolar Disorder (SERENITY III)
|
Phase 3 | |
| Not yet recruiting |
NCT05612711 -
Dronabinol for Agitation in Dementia Crossover Trial
|
Phase 2 | |
| Recruiting |
NCT04957238 -
Physical Restraints in Intensive Care Unit Patients
|
N/A | |
| Completed |
NCT03208452 -
The Effect of Intraoperative Magnesium Sulfate Infusion on the Occurrence of Emergence Agitation
|
Phase 4 | |
| Terminated |
NCT03899506 -
Olanzapine Versus Midazolam for Agitation
|
||
| Completed |
NCT03211897 -
Olanzapine, Haloperidol, Ziprasidone, Midazolam for Acute Undifferentiated Agitation
|
N/A | |
| Completed |
NCT04053426 -
Agitation Follow up After Introduction of a New Patient Care Algorithm
|
||
| Completed |
NCT03226522 -
Addressing Dementia Via Agitation-Centered Evaluation
|
Phase 2/Phase 3 | |
| Recruiting |
NCT03926520 -
Electroconvulsive Therapy (ECT) for Agitation in Dementia (AD)
|
N/A | |
| Recruiting |
NCT04075435 -
Cannabidiol Solution for the Treatment of Behavioral Symptoms in Older Adults With Mild Cognitive Impairment or Alzheimer's Dementia
|
Early Phase 1 | |
| Completed |
NCT04276883 -
Dexmedetomidine in the Treatment of Agitation Associated With Bipolar Disorder
|
Phase 3 | |
| Completed |
NCT04797715 -
Assessing Clinical Outcomes in Alzheimer's Disease Agitation
|
Phase 3 | |
| Completed |
NCT04251910 -
Sub-Lingual Dexmedetomidine in Agitation Associated With Dementia
|
Phase 1/Phase 2 | |
| Recruiting |
NCT05765162 -
Safe Brain Initiative, Operationalizing Precision Anaesthesia
|