Intranasal Dexmedetomidine vs. Standard of Care for Emergency Department (ED) Procedural Sedation in the Older Adult
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 主要终点
- Sedation
研究概览
简要总结
The purpose of the study is to determine if intranasal dexmedetomidine could be an alternative to the current standard of care (injectable benzodiazepines or antipsychotics) for sedation prior to computerized tomography (CT) or magnetic resonance imaging (MRI) in those greater than or equal to 65 years of age (older adults) that are seen in the Emergency Department (ED).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •65 years of age and older
- •Patients in need of sedation prior to either a computerized tomography (CT) or magnetic resonance imaging (MRI)
排除标准
- •Patients who weigh < 50 kg
- •Cardiac arrhythmias or QTc >450
- •Intravenous access not standard of care or unable to obtain
- •Patients with any allergies or contraindications to dexmedetomidine, haloperidol (i.e. patients diagnosed with Parkinson's) or lorazepam
- •Patients with low blood pressure, defined as a less than 100/60 mmHg
- •Patients with bradycardia (Heart rate < 60 bpm)
- •Patients presenting with chief complaint of respiratory distress/failure
- •Intranasal administration contradictions: nasal septal abnormalities, nasal trauma, epistaxis, excessive nasal mucus or blood, and intranasal damage, recent use of nasally administered vasoconstrictors such as cocaine, oxymetazoline, and phenylephrine
研究组 & 干预措施
Lorazepam
干预措施: Lorazepam (Drug)
Haloperidol
干预措施: Haloperidol (Drug)
IN Dex
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Sedation
时间窗: Within one hour of administration
The primary outcome is to determine if intranasal dexmedetomidine is as effective in producing moderate sedation on the Modified Observer's Assessment of Alertness/Sedation Scale (MOAAS) as standard of care intravenous medications in older adults. The minimum value on the Modified Observer's Assessment of Alertness/Sedation Scale is 0 and the maximum value is 5. Lower scores mean a worse outcome.
次要结局
未报告次要终点
研究者
Jay Brenner
Professor
State University of New York - Upstate Medical University