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临床试验/NCT02528825
NCT02528825已完成4 期

Effect-site Concentration of Remifentanil for Smooth Removal of the Double-lumen Endotracheal Tube

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2014年11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
25
试验地点
1
主要终点
Smooth emergence success or fail

研究概览

简要总结

Smooth emergence is important for patient safety and satisfaction. Coughing during emergence is associated with detrimental effects like laryngospasm, sore throat, hoarseness, negative pressure pulmonary edema and bleeding at surgical site 1. Especially sore throat and hoarseness are most common complications after extubation 2,3 and closely related to patient satisfaction 4. Using double lumen tube (DLT) increase the incidence of hoarseness and airway injury than using single lumen tube for it has large size5,6. Various technique and drugs have been proposed for reducing coughing during extubation including smooth emergence 1,7-11 and this is closely correlate with reducing sore throat and hoarseness 12. One of the proposed technique, the use of short acting opioids are prefered13-15 because it can be maintained during emergence with less respiratory depression. Remifentanil is a potent short acting opioid and several studies choose remifentanil combined with other anesthetic agents 1,15,16. There is a study about the EC50 and EC95 of remifentanil in effect site Target controlled infusion(TCI) for preventing cough during emergence after thyroidectomy with propofol-remifentanil anesthesia 15 but no study about the proper dose of remifentanil for smooth DLT extubation.

The purpose of this study was to evaluate the EC50 and EC95 of remifentanil in effect-site TCI for preventing cough during extubation of DLT in total TIVA with propofol and remifentanil.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ASA I-II,
  • Undergoing general anesthesia with DLT for lung wedge resection

排除标准

  • Anticipated difficult airway
  • Surgical duration of > 120 min,
  • Patient with gastroesophageal reflux or asthma, chronic obstructive disease and upper respiratory infection were excluded from the study.

研究组 & 干预措施

smooth emergence

Experimental

ASA I-II, aged 19-65 years undergoing general anesthesia with DLT for lung wedge resection were enrolled in this study.After completing the surgery, the propofol infusion was stopped, and effect-site concentration of remifentanil was titrated to predetermined concentration ( initial concentration being 1.5ng/ml for the first patient).The predetermined concentration was maintained at least 10 min throughout emergence for the effect site concentration and plasma concentration can be expected stable. The smooth emergence was defined as extubation without cough-a strong and sudden contraction of the abdomen. The predetermined concentration was decreased by 0.5 ng/ml for the next patient if the patient did not cough during emergence and similarly, if the patient coughed anytime during emergence, it was considered failed smooth emergence and predetermined concentration was increased by 0.5 ng/ml.

干预措施: Remifentanil titration (Drug)

结局指标

主要结局

Smooth emergence success or fail

时间窗: from the time of remifentanil equivalent state( postop 5 minute) to extubation

smooth emergence is success

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

Jiyoung Yoo

clinical assistant professor

Ajou University School of Medicine

研究点 (1)

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