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临床试验/NCT02455401
NCT02455401已完成不适用

Effect of Remifentanil on Postoperative Vomiting in Children Undergoing Strabismus Surgery During Sevoflurane Anesthesia

Inje University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年5月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
incidence of postoperative vomiting in PACU and surgical ward

研究概览

简要总结

The purpose of this study is to compare the effect of remifentanil on postoperative vomiting in children undergoing strabismus surgery during sevoflurane anesthesia.

详细描述

Children undergoing strabismus surgery frequently experience postoperative vomiting (POV) that results in dehydration, aspiration pneumonia, bleeding, delayed hospital discharge, as well as decreased parental satisfaction and an unpleasant experience for the pediatric patients. Although administration of perioperative opioids increases POV incidence, remifentanil has less affect the incidence of POV than other opioids such as fentanyl. However, there are few study that evaluate the effects of remifentanil on the incidence of POV. Therefore, the investigators will conducted the study that the effects of remifentanil on the incidence of POV in children undergoing strabismus surgery during sevoflurane anesthesia. One hundred five children from 3 to 6 yr of age, ASA physical status 1 or 2 were assigned randomly selected to one of three groups: high dose remifentanil group (bolus 1.0 mcg/kg; infusion 0.1 mcg/kg/min), low remifentanil group (bolus 0.5 mcg/kg; infusion 0.1 mcg/kg/min), or no remifentanil group (no remifentanil administration). Primary endpoint, the incidence of POV for 24 hours postoperatively, will be compared between three study groups.

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
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
3 Years 至 6 Years(Child)
性别
All
接受健康志愿者

入选标准

  • children undergoing elective strabismus surgery under sevoflurane anesthesia

排除标准

  • children who experienced postoperative retching or vomiting
  • children who have taken anti-emetic medications within 24 hours before surgery
  • children who experienced motion sickness

研究组 & 干预措施

high dose remifentanil group

Experimental

Intervention: high dose remifentanil will be administrated.

干预措施: High dose remifentanil (Drug)

low dose remifentanil group

Experimental

Intervention: low dose remifentanil will be administrated

干预措施: Low dose remifentanil (Drug)

No remifentanil group

Placebo Comparator

Intervention: no remifenatnil will be administrated

干预措施: No remifentanil (Drug)

结局指标

主要结局

incidence of postoperative vomiting in PACU and surgical ward

时间窗: from extubation to 24 hours

Vomiting is expulsion of gastric contents. Incidence of vomiting will be compared between the groups.

次要结局

  • postoperative pain in PACU and surgical ward(from extubation to 24 hours)
  • postoperative emergence agitation(from extubation to 24 hours)

研究者

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

Ki Hwa Lee

Assistant Professor

Inje University

研究点 (1)

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