NCT04096768Unknown3 期
Combining Dexmedetomidine and Ketamine in Intensive Care Sedation: Efficacy and Safety
Lebanese American University Medical Center1 个研究点 分布在 1 个国家目标入组 394 人开始时间: 2019年9月16日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 394
- 试验地点
- 1
- 主要终点
- Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only
研究概览
简要总结
The aim of the study is to compare the use of dexmedetomidine + ketamine with dexmedetomidine + placebo for sedation in ICU patients in terms of safety and efficacy
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80 years old
- •Admitted to Intensive care unit at LAUMCRH
- •Need for sedation for at least 24 hours
- •Informed Consent Form signed by patient or surrogate
排除标准
- •Pregnant patients
- •At risk of increased intracranial pressure
- •Aortic dissection
- •Acute coronary syndrome
- •Hypertension (SBP > 180 mmHg)
- •Chronic alcoholism
- •Acute alcohol intoxication
- •Alcohol withdrawal
- •Refractory status epilepticus
- •History of psychiatric disorder
- •Known allergy or contraindication to use of dexmedetomidine or ketamine
- •Baseline hypotension (MAP<65 mmHg)
- •Baseline bradycardia (HR<48 bpm)
- •Patients receiving neuromuscular blocking agents
- •Patients requiring deep sedation as determined by the ICU attending
研究组 & 干预措施
Dexmedetomidine + Ketamine
Experimental
干预措施: Dexmedetomidine (Drug)
Dexmedetomidine + Ketamine
Experimental
干预措施: Ketamine (Drug)
Dexmedetomidine + Placebo
Placebo Comparator
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only
时间窗: Within 24 hours of drugs administration
Measuring blood pressure to assess hypotension when using a combination of the two drugs for sedation versus Dexmedetomidine and placebo only
次要结局
- Measuring the doses of dexmedetomidine and ketamine when combined and the doses of dexmedetomidine when used alone to achieve desired level of sedation(Within 24 hours of drugs administration)
研究者
Fayez Abillama, MD
Intensive Care Medicine Physician
Lebanese American University Medical Center
研究点 (1)
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