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临床试验/NCT02379715
NCT02379715已完成4 期

Effect-site Concentration of Remifentanil for Smooth Induction With Desflurane

Ajou University School of Medicine0 个研究点目标入组 26 人开始时间: 2014年12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
26
主要终点
Fail or success for induction with desflurane

研究概览

简要总结

Desflurane is a halogenated ether with low solubility, giving rapid induction and emergence from anesthesia This character is suitable for Volatile Induction and Maintenance Anesthesia (VIMA). But desflurane can cause airway irritation when it used as a sole induction agent to adult or children, so there were many studies about reducing the airway reflex combined with desflurane.

Remifentanil is a short acting opioid and is quickly hydrolyzed by nonspecific esterase in the plasma and multiorgan. Several studies suggest the optimal dose of remifentanil for reducing airway reflex or cardiovascular response for intubation combined with desflurane. But these studies were under 1 Minimal Alveolar Concentration (MAC) of desflurane and this point could be a limitation because desflurane concentration over 1 MAC increase airway irritation significantly. This study this study was designed to determine a median effective effect-site concentration (EC50) of remifentanil to prevent airway irritation during desflurane anesthesia over 1 MAC.

研究设计

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

入排标准

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

入选标准

  • patients for surgery requiring general anesthesia
  • American Society of Anesthesiologists(ASA) classification I, II

排除标准

  • history of gastroesophageal reflux, High grade obesity, Predicted difficult airway, Asthma, Chronic obstructive pulmonary disease(COPD), Upper respiratory infection (URI) within 3 weeks

研究组 & 干预措施

Remifentanil

Experimental

When the particapants arrived into the operating room, the investigators applied standard monitoring and after preoxygenation, 2 mg remifentanil was diluted into 50 ml of normal saline (40 μg/ml solution) and was infused by Target concentration infusion (TCI) via syringe pump (Pilot Anesthesia 2. Fresenius vial, France) using the pharmacokinetic model. Investigator started to infuse remifentanil at 4 ng/ml and after the Ce of remifentanil reached the target concentration level, opened the dial of desflurane vaporizer at 4 vol%. After 30 seconds, increase the concentration of desflurane 8% and 12% at last. If there is no spontaneous respiration or loss of consciousness, the muscle relaxant esmerone 0.6mg/kg is injected and after 90 seconds the tracheal intubation is performed.

干预措施: Remifentanil (Drug)

Remifentanil

Experimental

When the particapants arrived into the operating room, the investigators applied standard monitoring and after preoxygenation, 2 mg remifentanil was diluted into 50 ml of normal saline (40 μg/ml solution) and was infused by Target concentration infusion (TCI) via syringe pump (Pilot Anesthesia 2. Fresenius vial, France) using the pharmacokinetic model. Investigator started to infuse remifentanil at 4 ng/ml and after the Ce of remifentanil reached the target concentration level, opened the dial of desflurane vaporizer at 4 vol%. After 30 seconds, increase the concentration of desflurane 8% and 12% at last. If there is no spontaneous respiration or loss of consciousness, the muscle relaxant esmerone 0.6mg/kg is injected and after 90 seconds the tracheal intubation is performed.

干预措施: Desflurane (Drug)

结局指标

主要结局

Fail or success for induction with desflurane

时间窗: After loss of consciousness, 5 seconds

Failure for induction with desflurane is defined if there is a cough, laryngospasm, hypoxia or any refusal movement of patient.

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

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