S-KETamine vs. propofol for prehospital sedation of patients with severe Acute Brain Injury: The KETABI randomised trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 284
- 试验地点
- 1
- 主要终点
- Lowest mean arterial pressure (MAP) recorded during the intervention period referring to the period from administration of the investigational medicinal product until the departure from the trauma centre.
研究概览
简要总结
This trial aims to compare the efficacy of S-ketamine versus propofol in preventing hypotension during the study period among patients with severe acute brain injury who require prehospital sedation, intubation, and mechanical ventilation. The study period is defined as the interval from the first prehospital blood pressure measurement to the last blood pressure measurement recorded in the trauma centre before transfer, inclusive of both measurements.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years (presumed if not known)
- •Presumed severe spontaneous or traumatic primary ABI
- •Decision to sedate and intubate prehospitally
- •Expected direct transfer from the prehospital setting to a hospital providing highly specialised intensive care for severe acute brain injury
排除标准
- •Patients for whom the prehospital physician considers either S-ketamine or propofol to be contraindicated
- •Known allergy to S-ketamine or propofol
- •Out-of-hospital cardiac arrest (OCHA) of any cause, verified by prehospital personnel
研究组 & 干预措施
S-ketamin "Pfizer" injektionsvæske, opløsning
干预措施: S-ketamin "Pfizer" injektionsvæske, opløsning (Drug)
PROPOFOL
干预措施: PROPOFOL (Drug)
结局指标
主要结局
Lowest mean arterial pressure (MAP) recorded during the intervention period referring to the period from administration of the investigational medicinal product until the departure from the trauma centre.
Lowest mean arterial pressure (MAP) recorded during the intervention period referring to the period from administration of the investigational medicinal product until the departure from the trauma centre.
次要结局
- Episode(s) of hypotension (MAP <60 mmHg) measured in the intervention period
- Episode(s) of hypertension (MAP >130 mmHg) measured in the intervention period
- Episode(s) of hypoxaemia (two successive measurements of SpO2<94%) measured in the intervention period
- Functional outcome using GOSE six months after randomisation (1–8 scale)
- Functional outcome using mRS six months after randomisation (1–6 scale)
研究者
Kirsten Møller
Scientific
Region Hovedstaden