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临床试验/NCT01456299
NCT01456299已完成不适用

Target-controlled Infusion of Remifentanil for Laryngeal Mask Airway Insertion During Sevoflurane Induction in Adults

Gachon University Gil Medical Center1 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2011年4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
102
试验地点
1
主要终点
LMA Insertion Condition

研究概览

简要总结

The purpose of this study was to determine the most suitable effect-site concentration of remifentanil for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

详细描述

For practical purposes, opioids with the ability to suppress upper airway reflexes have been used to facilitate insertion of the LMA during anaesthesia induction. To date, however, there have been no published reports addressing the use of remifentanil to facilitate LMA insertion during sevoflurane inhalation induction in adults. Therefore, the purpose of this study was to determine the most suitable effect-site concentration of remifentanil target-controlled infusion (TCI) for the LMA insertion during inhaled induction with 8% sevoflurane in adults.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

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

入选标准

  • Adult patients, aged 18-60 with ASA physical status I or II, who were scheduled to minor elective surgery (< 1 h) were considered for the study

排除标准

  • Exclusion criteria were allergies to the study drugs, a history of gastric reflux, a history of drug abuse, obesity (body mass index > 30 kg/m2) and suspected difficult airway

研究组 & 干预措施

Control

Placebo Comparator

The control group, which received an infusion of normal saline.

干预措施: Control (Drug)

Remifentanil 1

Active Comparator

"Remifentanil 1": "The R1 group, which received a target effect-site remifentanil concentration of 1 ng/ml.

干预措施: Remifentanil 1 (Drug)

Remifentanil 2

Active Comparator

"Remifentanil 2": "The R2 group, which received a target effect-site remifentanil concentration of 2 ng/ml.

干预措施: Remifentanil 2 (Drug)

结局指标

主要结局

LMA Insertion Condition

时间窗: at that time on LMA insertion only

The pre-determined effect-site concentration of remifentanil or normal saline was administered according to the patient's group.LMAs were size #3 for women and #4 for men.The conditions of the LMA insertion were graded on a three point scale using six variables (mouth opening, ease of LMA insertion, swallowing, coughing and gagging, head and body movements, laryngospasm). Each of these variables was rated as excellent, intermediate or poor.

次要结局

  • Frequency of Apnea(baseline, 30sec after drug injection)

研究者

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

Hyun Jeong Kwak

Associate Professor

Gachon University Gil Medical Center

研究点 (1)

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