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临床试验/NCT02382354
NCT02382354已完成4 期

Comparison of the Effect-site Concentration of Remifentanil for Insertion of the I-gel and Laryngeal Mask Airway During Propofol Anesthesia

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2015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
发起方
入组人数
41
试验地点
1
主要终点
successful insertion of i-gel and LMA

研究概览

简要总结

Structural differences of supraglottic airway devices could influence the different compressive forces in the oropharyngeal cavities, and require different depth of anesthesia. The addition of remifentanil during propofol anesthesia facilitates the insertion of laryngeal mask airway (LMA) with minimal adverse hemodynamic disturbances. This study was designed to determine the effect-site concentration of remifentanil in 50% of patients (EC50) and 95% of patients (EC95) for successful i- gel insertion, and compare those for LMA insertion during propofol target-controlled infusion (TCI).

详细描述

Anesthesia was induced with propofol TCI at the effect-site concentration of 5 μg/ml, and the predetermined effect-site concentration of remifentanil was started simultaneously. The remifentanil concentration was determined using modified Dixon's up-and-down method (initial concentration: 3.0 ng/ml, step size: 0.5 ng/ml). Five minutes later, i- gel or LMA insertion was attempted. The response of the patients to the insertion of LMA was classified as either 'movement' or 'no movement'.

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
Single (Participant)

入排标准

年龄范围
19 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • ASA I-II patients undergoing general anesthesia for short elective surgery (<2 hr)

排除标准

  • G-E reflux
  • obesity (BMI>30)
  • anticipated difficult airway

研究组 & 干预措施

i-gel

Experimental

I-gel insertion was attempted during propofol and remifentanil anesthesia .

干预措施: remifentanil (Drug)

i-gel

Experimental

I-gel insertion was attempted during propofol and remifentanil anesthesia .

干预措施: i-gel (Device)

i-gel

Experimental

I-gel insertion was attempted during propofol and remifentanil anesthesia .

干预措施: propofol (Drug)

laryngeal mask airway

Active Comparator

LMA insertion was attempted during propofol and remifentanil anesthesia .

干预措施: remifentanil (Drug)

laryngeal mask airway

Active Comparator

LMA insertion was attempted during propofol and remifentanil anesthesia .

干预措施: laryngeal mask airway (Device)

laryngeal mask airway

Active Comparator

LMA insertion was attempted during propofol and remifentanil anesthesia .

干预措施: propofol (Drug)

结局指标

主要结局

successful insertion of i-gel and LMA

时间窗: from 5 min after anesthetic induction to 1min after device insertion

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

Associate professor

Ajou University School of Medicine

研究点 (1)

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