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临床试验/NCT01901588
NCT01901588已完成4 期

Efficacy of Single-Shot Dexmedetomidine Versus Placebo in Preventing Pediatric Emergence Delirium in Strabismus Surgery

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 63 人开始时间: 2012年3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
63
试验地点
1
主要终点
Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery

研究概览

简要总结

This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.

详细描述

Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay.

Inclusion:

i. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities

Exclusion:

i. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
1 Year 至 7 Years(Child)
性别
All
接受健康志愿者

入选标准

  • ASA physical status of I or II
  • male or female, aged 1-7
  • has no significant lab abnormalities

排除标准

  • ASA physical status of III, IV or V
  • Presence of medicated behavioral disorder
  • Subjects for which dexmedetomidine, opiates, benzodiazepines or inhalational anesthetics are contraindicated.
  • Parental refusal

研究组 & 干预措施

Dexmedetomidine

Experimental

dexmedetomidine/precedex

干预措施: Dexmedetomidine (Drug)

Placebo

Placebo Comparator

patients receive saline solution.

干预措施: Placebo (Other)

结局指标

主要结局

Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery

时间窗: Length of PACU stay (around 3 hours on average)

次要结局

  • Time to PACU Discharge(Length of PACU stay (around 3 hours on average))
  • Percentage of Participants Receiving Pain Medication(Length of PACU stay (around 3 hours on average))
  • Post-op Pain Interventions(Length of PACU stay (around 3 hours on average))
  • Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications(Length of PACU stay (around 3 hours on average))
  • Time to Arousal(Length of PACU stay (around 3 hours on average))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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