CTIS2023-510201-18-00进行中（未招募）1 期
Advancing the quality of treatment and care for acute agitation in emergency psychiatry
Psykiatrisk Center Kobenhavn0 个研究点目标入组 132 人开始时间: 2024年3月15日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 132
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 64（—）
- 性别
- All
入选标准
- •18-64 years, Agitation with the need for tranquillization in inpatient psychiatric settings including psychiatric emergency rooms, Total score of =14 on the PANSS Excited Component (PEC), A score =4 on at least 1 of the 5 items of the PEC, Informed consent obtained prior to the occurrence of the emergency
排除标准
- •Involuntary psychiatric admission according to the Danish Mental Health Act, Use of benzodiazepines, other sedatives, or antipsychotic drugs in addition to usual treatment (i.e., additional PN sedative prescriptions) in the 4 hours before study treatment, Known allergy to any of the study medications, Female patients who are breastfeeding, Female patients aged <50 years and unable to perform a negative urine screen for pregnancy and not using safe contraceptives, Body weight <50 kg, Extreme obesity defined as estimated BMI= 40 kg/m2, Clinical situations where acute administration of an antipsychotic is preferred to treat acute agitation (in the opinion of the investigator), The patient deemed unwilling or unable to cooperate with study procedures (in the opinion of the investigator), Insufficient language skills that interfere with reading, writing, and providing written informed consent in Danish or other available languages (in the opinion of the investigator), Clinical suspicion of contraindications for one of the treatment arms: severe hepatic impairment, hypotension (systolic blood pressure <90 mmHg), bradycardia (heart rate <60 bpm), 2nd or 3rd degree atrioventricular block in patients without pacemaker, severe ventricular dysfunction, known QTc prolongation, respiratory impairment (need for oxygen supplementation to keep SpO2=92% or SpO2=88% in patients with COPD), and sleep apnea
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