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临床试验/NCT04455711
NCT04455711Unknown不适用

The Efficacy of Intravenous Lidocaine With Continuous Infusion of Remifentanil for Attenuating Double Lumen Tube Induced Cough During Emergence

Ajou University School of Medicine1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2020年7月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
发起方
入组人数
80
试验地点
1
主要终点
Cough incidence

研究概览

简要总结

Cough suppression during emergence and tracheal extubation from general anaesthesia has become an important issue as part of patient safety. Cough arised from the mechanical irritation of endotracheal tube and cuff could be accompanied by various adverse effects such as laryngospasm, hypertension, tachycardia, arrhythmia and increase of intracranial, intraocular, or intra-abdominal pressure.

Several cough-preventing strategies have been proposed for smooth emergence, such as opioids, dexmedetomidine or lidocaine. Maintenance of remifentanil infusion during emergence has been reported to be an effective method in reducing cough and cardiovascular change without delay of recovery. In previous studies, the effetive effect-site concentraions for 95% of adults (EC95) for preventing cough are a little different depending on anaestheic agent, type of surgery and sex, ranged from 2.14 to 2.94 ng/ml. However, since most of these studies are for sing lumen endotracheal tube, similar preventing effect would not be expected for double lumen tube (DLT) because of its large diameter and long length. Another problem is higher concentration of remifentanil more than 2.5 ng/ml could not guarantee the safety after extubation. The efficacy of a single IV bolus of lidocaine for the prevention of cough has been the subject of numerous trials.

Therefore, combined use of lidocaine and remifentanil could effectively prevent emergence cough for DLT without the risk of high concentration of remifentanil.

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
Double (Participant, Investigator)

入排标准

年龄范围
19 Years 至 75 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • Patients needs for double lumen tube intubation for one lung ventilation during surgery with ASA (American society of Anesthesiologists) class I or II

排除标准

  • Gastroesophageal reflux disease
  • Obese patients (BMI > 30)
  • Recent upper respiratory infection history (within 3 weeks)
  • Asthma history
  • Anticipating difficult airway

研究组 & 干预措施

Remifentanil group

Placebo Comparator

Emerge with continuous infusion of remifentanil 1.5 ng/ml

干预措施: Remifentanil (Drug)

Lidocaine group

Experimental

Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg

干预措施: Lidocaine Iv (Drug)

Lidocaine group

Experimental

Emerge with continuous infusion of remifentanil 1.5 ng/ml with IV bolus of lidocaine 1.5 mg/kg

干预措施: Remifentanil (Drug)

结局指标

主要结局

Cough incidence

时间窗: from the time of end of the operation up to 10 min after extubation

次要结局

  • Cough severity(from the time of end of the operation up to 10 min after extubation)
  • hoarseness(30 min at the recovery room)

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

Assistant professor

Ajou University School of Medicine

研究点 (1)

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