跳至主要内容
临床试验/NCT01748630
NCT01748630已完成4 期

Pain, Fentanyl Consumption, and Delirium in Children After Scoliosis Surgery: Dexmedetomidine Versus Midazolam

Inonu University1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
42
试验地点
1
主要终点
fentanyl consumption

研究概览

简要总结

Background: The study aim was to compare the efficacy of dexmedetomidine versus midazolam for sedation during the early postoperative period in children who underwent scoliosis surgery.

Methods: We performed a prospective, randomized trial in an intensive care unit (ICU) in a tertiary care center. In this study, 42 patients (American Society of Anesthesiology physical status I and II) who underwent scoliosis surgery were divided into 2 groups according to sedation protocols: group DEX (n = 22) and group MDZ (n = 20). Children (12-18 years) requiring mechanical ventilation underwent a continuous infusion of either dexmedetomidine (group DEX; starting dose, 0.4 μg•kg-1•h-1) or midazolam (group MDZ; starting dose, 0.1 mg•kg-1•h-1) with intermittent fentanyl, as needed. The efficacy of sedation was assessed using the Richmond Agitation Sedation Scale (RASS). Quality of pain relief was measured using the Numeric Visual Analog Scale (NVAS). During the arousal assessment, delirium was determined in patients in the RASS range of -2 to +1 using the Confusion Assessment Method for the ICU (CAM-ICU). Fentanyl consumption, incidence of delirium, NVAS scores, and hemodynamics were recorded postoperatively at 2, 4, 6, and 24 h in the ICU.

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
Double (Participant, Investigator)

入排标准

年龄范围
12 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • admittance to the ICU and a requirement of mechanical ventilation with an endotracheal tube.

排除标准

  • Patients who had a history of allergies to midazolam and/or dexmedetomidine; delirium, developmental delay, or mental retardation, as reported by parents; an American Society of Anesthesiologists classification greater than III; any known previous reactions to anesthesia; or a history of asthma or an anticipated difficult airway and concomitant disease (neuromuscular scoliosis or neurodegenerative disease) were excluded from the study.

研究组 & 干预措施

Dexmedetomidine, Midazolam

Active Comparator

dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl

干预措施: dexmedetomidine (Drug)

Dexmedetomidine, Midazolam

Active Comparator

dexmedetomidine (group DEX); starting dose, 0.4 μg•kg-1•h-1,with intermittent fentanyl

干预措施: fentanyl (Drug)

Midazolam

Active Comparator

midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1

干预措施: Midazolam (Drug)

Midazolam

Active Comparator

midazolam (group MDZ); starting dose, 0.1 mg•kg-1•h-1

干预措施: fentanyl (Drug)

结局指标

主要结局

fentanyl consumption

时间窗: 24 hours

次要结局

  • incidence of delirium(1, 2, 4 ,6 and 24 hours)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Mustafasaid

Assist. Prof.

Inonu University

研究点 (1)

Loading locations...

相似试验