跳至主要内容
临床试验/NCT03401606
NCT03401606终止4 期

Dexmedetomidine vs. Remifentanil for Patient and Surgeon Satisfaction in Cataract Surgery Under Controlled Sedation

Fundación Universitaria de Ciencias de la Salud0 个研究点目标入组 98 人开始时间: 2014年11月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
终止
发起方
入组人数
98
主要终点
Surgeon and patient satisfaction

研究概览

简要总结

This study evaluates the surgeon and patient´s satisfaction who undergoes cataract surgery using either dexmedetomidine or remifentanil as sedation

详细描述

This is a double blind, randomized study which evaluates surgeon and patient´s satisfaction whom undergoes cataract surgery. The surgery was done under local anesthesia and sedation.

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, Outcomes Assessor)

入排标准

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

入选标准

  • subject has cataract,
  • subject older than 18 years,
  • local anesthesia and sedation.

排除标准

  • general anesthesia,
  • history of consumption of sedatives.

研究组 & 干预措施

Remifentanil

Active Comparator

remifentanil and dexmedetomidine, 0.25 ng/mL, given intravenous, infusion, until surgery finished.

干预措施: remifentanil (Drug)

Dexmedetomidine

Active Comparator

dexmedetomidine and remifentanil, 0.125 mcg/kg/hour, given intravenous, infusion, until surgery finished

干预措施: Dexmedetomidine (Drug)

结局指标

主要结局

Surgeon and patient satisfaction

时间窗: Intraoperative

It was evaluated with an absolute numerical subjective scale from 1 to 7, where a score of 1 means total dissatisfaction, and 7 complete satisfaction. Scores were evaluated 30 minutes after surgery begun and at the end of the procedure. Results are presented in median and interquartile ranges.

次要结局

  • Heart rate(Intraoperative)
  • Mean arterial pressure(Intraoperative)
  • Hemoglobin oxygen saturation(Intraoperative)
  • Surgery duration(Intraoperative)

研究者

发起方
Fundación Universitaria de Ciencias de la Salud
申办方类型
Other
责任方
Sponsor

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