Ketamine for Sedation in Severe Traumatic Brain Injury
试验速览
- 阶段
- 4 期
- 状态
- 暂停
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Mean ICP
研究概览
简要总结
This protocol is for an open-label randomized trial evaluating the safety of using ketamine in combination with propofol for sedation versus the standard of care analgosedation in patients admitted to the intensive care unit with severe traumatic brain injury.
详细描述
Patients meeting eligibility criteria and consent having been obtained by LAR will undergo randomization to either the ketamine with propofol intervention arm or the standard of care control arm.
Patients enrolled in the intervention arm will receive propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine, for sustained ICP elevations over 22mHg for greater than 5 minutes not attributed to other causes (coughing etc.). In the control arm, patients will receive their institutional analgosedation protocol. The sedation protocols will be continued until removal of intracranial pressure monitoring.
This study will take place during the participant's hospital care. The clinical team will administer treatment using standard practices, including all safety precautions available. Side effects will be monitored closely and may decide to discontinue the subject's participation in the study should the subject's health or safety are at risk.
The research team will performed one outpatient follow-up after study intervention ends.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 18-65 years of age
- •Severe traumatic brain injury (TBI), with a Glasgow Coma Scale (GCS) ≤ 8, requiring intracranial monitoring
- •Placement of intracranial pressure monitor
- •Receiving treatment in an intensive care unit (ICU)
排除标准
- •Significant cardiovascular disease with recent coronary intervention
- •Pregnancy
- •Prisoners
- •Known allergy to ketamine or propofol
研究组 & 干预措施
Ketamine with propofol
Propofol at a rate of 300 mcg/kg/hr (5 mcg/kg/min) with the addition of ketamine at a rate of 1000-5000 mcg/kg/hr (16.67 - 83.33 mcg/kg/min) (using weight at time of admission) with an additional 2 mg/kg (2000 mcg/kg) bolus of ketamine
干预措施: Ketamine with propofol (Drug)
SOC propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam
Standard of Care analgosedation of choice using propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam.
干预措施: Standard of Care propofol, fentanyl, dexmedetomidine, morphine, hydromorphone, midazolam, or lorazepam (Other)
结局指标
主要结局
Mean ICP
时间窗: During the maximum 5-day course of study intervention.
Mean ICP
Number of ICP elevations greater than 22 mmHg for greater than 5 minutes
时间窗: During the maximum 5-day course of study intervention, while patient is sedated and has intracranial pressure monitor in place in the ICU setting
ICP elevations \> 22 mmHg for greater than 5 minutes.
次要结局
- Mean heart rate(During the maximum 5-day course of study intervention.)
- Vasopressor dependency index (VDI)(During the maximum 5-day course of study intervention.)
- Total time spent with intracranial pressure (ICP) >22 mmHg(During the maximum 5-day course of study intervention.)
- Total time spent with CPP <60 mmHg(During the maximum 5-day course of study intervention.)
- Incidence of seizures(During the maximum 5-day course of study intervention.)
- Incidence of cardiac arrhythmias(During the maximum 5-day course of study intervention.)
- Incidence of post-traumatic stress disorder (PTSD) in outpatient setting(Outpatient follow-up six months after intervention.)
- Mean Cerebral Perfusion Pressure (CPP)(During the maximum 5-day course of study intervention.)
- Total number of events where CPP <60 mmHg for greater than 5 minutes(During the maximum 5-day course of study intervention.)
- Glasgow Coma Outcome Scale extended (GOSE-TBI) scores(Outpatient follow-up six months after intervention.)