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临床试验/NCT03330782
NCT03330782已完成4 期

Effect-site Concentration of Remifentanil for Preventing Propofol Injection Pain in Elderly Patients: A Comparison With Adult Patients

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2017年11月16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
已完成
发起方
入组人数
52
试验地点
1
主要终点
Severity of propofol injection pain-4 point scale

研究概览

简要总结

Elderly patients show different pharmacokinetic and pharmacodynamic variables and usually need smaller doses of anesthetic drugs than younger patients. The purpose of this study was to investigate the optimal effect-site concentration of remifentanil for preventing injection pain during propofol induction in elderly patients by the Dixon's up-and-down method.

研究设计

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

入排标准

年龄范围
19 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • ASA physical status I or II undergoing general anesthesia

排除标准

  • neurologic disorder
  • psychologic disorder
  • vascular disorder
  • patients with chronic pain
  • difficulty in vascular access

研究组 & 干预措施

Elderly

Experimental

Remifentanil was infused at predetermined effect-site concentration before propofol infusion in elderly patients.

干预措施: Remifentanil (Drug)

Adult

Active Comparator

Remifentanil was infused at predetermined effect-site concentration before propofol infusion in adult patients.

干预措施: Remifentanil (Drug)

结局指标

主要结局

Severity of propofol injection pain-4 point scale

时间窗: during 3 min after remifentanil and propofol infusion to reach the equilibrium of plasma and effect-site concentration

0 = no pain (negative response to questioning), 1. = mild pain (pain reported only in response to questioning without any behavioral signs), 2. = moderate pain (pain reported in response to questioning and accompanied by a behavioral signs or pain reported spontane¬ously without questioning), 3. = severe pain (vocal response accompanied by facial grimacing, arm withdrawal, or tears)

次要结局

未报告次要终点

研究者

发起方
Ajou University School of Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jong Yeop Kim

Professor

Ajou University School of Medicine

研究点 (1)

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