Efficacy and Safety of Dexmedetomidine Sedation in Spontaneous Breathing Patients After Tracheal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- The primary endpoint is the efficacy in changing the sedation level during the infusion
研究概览
简要总结
Patients undergoing tracheal resection and reconstruction surgery are enrolled in this prospective observational pilot study to evaluate dexmedetomidine-based sedation after tracheal surgery in an Intensive Care Unit (ICU). Patients remain electively intubated with an uncuffed nasal endotracheal tube, awake and exhibit spontaneous breathing The neck was maintained in flexion through chin-to-chest sutures. Infusion of dexmedetomidine was started from a dosage of 0.7 μg kg-1 h-1 followed by dose titration to the target level of the sedation Richmond Agitation Sedation Scale, (RASS) score -1/-2 using a dose range of 0.2-1.4 μg kg-1 h-1.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients submitted to tracheal surgery
- •elective surgery
- •age ≥ 18 years
排除标准
- •severe neurological disorder
- •visual or hearing impairment
- •acute cerebrovascular disease
- •mean arterial pressure (MAP) <55 mmHg or hypotension requiring the use of inotropes/vasopressors
- •heart rate (HR) <50 bpm
- •second and third degree atrioventricular block (AV block) in the absence of PMK
- •Sequential Organ Failure Assessment (SOFA) score <2 index
- •hepatic failure
- •emergency surgery
- •pregnancy
- •patient refusal to give consent
- •inability to give consent
- •age ≤18 years
- •ASA score ≥ IV.
结局指标
主要结局
The primary endpoint is the efficacy in changing the sedation level during the infusion
时间窗: at T0 (baseline) and 12 hours from the beginning of the infusion
monitored through the sedation scale called Richmond Agitation-Sedation Scale(RASS).RASS is a medical scale used to measure the agitation or sedation level of a person.The score ranges from +4 "combative" to -5 "unarousable". The target level of the sedation is a RASS score -1/-2 .
次要结局
- The secondary endpoint is evaluation of safety throughout the incidence of adverse effects during the infusion(at T0 (baseline), 3, 6, 12 and 18 hours from the beginning of the infusion))
研究者
Silvia Fiorelli
principal investigator
University of Roma La Sapienza