Dexmedetomidine vs. Midazolam for Facilitating Extubation in Medical and Surgical ICU Patients: A Randomized, Double-Blind Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Time From Study Drug Initiation to Tracheal Extubation
研究概览
简要总结
The purpose of this randomized, double-blind study is to evaluate the utility, safety, and cost of transitioning benzodiazepine sedation to dexmedetomidine in medical or surgical intensive care unit (ICU) patients requiring sedation when tracheal extubation is nearing. Fifty medical or surgical ICU patients requiring sedation with existing benzodiazepine therapy and qualifying for daily awakenings will be randomized in a double-blind manner to receive additional midazolam or dexmedetomidine.
详细描述
This study is unique because midazolam or dexmedetomidine will be added, in a blinded fashion, to existing sedation and analgesia in an effort to decrease or possibly discontinue these therapies.
Objectives:
The objectives of this study are to determine if transitioning conventional sedation to dexmedetomidine safely facilitates tracheal extubation after study initiation; alters the amounts of sedative and analgesic agents required after study initiation; influences the levels of sedation and analgesia; alters the adverse event profile (neurologic, hemodynamic, or gastrointestinal) during and after discontinuing sedation; and impacts the total cost of sedation during and after discontinuing sedation.
Hypothesis 1: Transitioning conventional sedation to dexmedetomidine expedites tracheal extubation to shorten ventilator time.
Specific Aim 1: Comparatively determine the time from study initiation to tracheal extubation with midazolam and dexmedetomidine when the practice of daily awakenings is used.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients requiring mechanical ventilation in the medical or surgical ICUs.
- •Currently receiving lorazepam or midazolam by continuous infusion for the purpose of sedation therapy.
- •Sedation in these ICUs is provided using an ICU-wide order form that preferentially uses either lorazepam or midazolam with the infusion rate titrated by the bedside nurse to the desired Riker sedation-agitation score(s). Continuous analgesia is provided with fentanyl only with the infusion rate titrated by the bedside nurse to PABS ≤ 3 .
- •Anticipated duration of continuous sedation > 12 hours with the level of sedation expected to be maintained at Riker sedation-agitation score(s) of 3 -
- •Patients qualifying for daily awakenings as determined by all of the following:
- •fraction of inspired oxygen (FiO2) ≤ 70% or
- •positive end expiratory pressure (PEEP) ≤ 14 cmH2O,
- •hemodynamically stable, and
- •NOT receiving pharmacologic neuromuscular blockade.
- •Informed consent and HIPAA authorization within 24 hours of qualifying for daily awakenings.
排除标准
- •Patients < 18 years of age or > 85 years of age.
- •Patients receiving intermittent or "as needed" administration of lorazepam or midazolam.
- •Patients receiving lorazepam or midazolam for purposes other than sedation (e.g. seizure control).
- •Patients receiving epidural administration of medication(s).
- •Patients with Childs-Pugh class C liver disease.
- •Comatose patients by metabolic or neurologic affectation.
- •Patients with active myocardial ischemia or second- or third-degree heart block.
- •Moribund state with planned withdrawal of life support.
- •Patients with known or suspected severe adverse reactions to midazolam (or any other benzodiazepine) or dexmedetomidine (or clonidine).
- •Patients with alcohol abuse within six months of study eligibility.
- •Pregnant females or females suspected of being pregnant.
研究组 & 干预措施
Midazolam
Midazolam infusion of 1 mg/hour (final infusion concentration of 0.5 mg/mL) and adjusted by 1 mg/hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4) as other sedatives are down titrated. Daily awakenings are used.
干预措施: Midazolam (Drug)
Dexmedetomidine
Dexmedetomidine 0.15 µg/kg per hour (final infusion concentration of 0.075 µg/kg per mL) and adjusted by 0.15 µg/kg per hour by the bedside nurse as needed for the desired level of sedation (Riker sedation-agitation score of 3 - 4)as other sedatives are down titrated. Daily awakenings are used.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
Time From Study Drug Initiation to Tracheal Extubation
时间窗: Duration of ICU stay, for up to 24 weeks
次要结局
- The Quality of Sedation (Assessed by the Riker Sedation-Agitation Score) and Analgesia (Assessed by the Pain Assessment Behavioral Score)(Duration of ICU stay, for up to 24 weeks)
- Cumulative Doses of Conventional Sedatives and Analgesics(Duration of ICU stay, for up to 24 weeks)
- Hospital Anxiety and Depression Scale (HADS) Score(Duration of hospital stay, up to 24 weeks)
- Sedation-related Adverse Effects(Duration of ICU stay, up to 24 weeks)
- ICU Experiences by Administering ICU Stressful Experiences Questionnaire (ICU-SEQ)(Duration of hospital stay, up to 24 weeks)
- Duration of Study Drug Administration(Duration of ICU stay, up to 24 weeks)
- Manifestations of Acute Stress Disorder by Impact of Event Scale - Revised (IES-R)(Duration of hospital stay, up to 24 weeks)