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临床试验/NCT01451840
NCT01451840已完成不适用

Efficacy of Alkalinized Lidocaine in the Endotracheal Tube Cuff Compared to a Bolus Dose of Intravenous Remifentanil on the Incidence of Coughing During Emergence of Anesthesia

Centre hospitalier de l'Université de Montréal (CHUM)1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2012年1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
发起方
入组人数
85
试验地点
1
主要终点
Incidence of coughing during emergence and after extubation

研究概览

简要总结

This study is designed to compare the effects of alkalinized lidocaine in the endotracheal tube cuff to a bolus dose of remifentanil given prior to the emergence of anesthesia:

  • on the incidence of perioperative coughing
  • on the time needed for the emergence of a desflurane-based anesthesia
  • on the incidence of sore throat after extubation.

The investigators hypothesis is that the use of alkalinized lidocaine in the endotracheal tube cuff will reduce the incidence of perioperative coughing after a desflurane-based anesthesia.

详细描述

Emergence is an important period of general anesthesia during which several problems can occur. Coughing, hypertension, tachycardia and agitation have been observed during emergence of general anesthesia.

Desflurane is a newer volatile agent allowing early recovery from anesthesia. This agent has led to earlier discharge and more rapid resumption of normal activities after surgery. However, an incidence of coughing around 70% has been reported after a desflurane-based anesthesia. Different techniques and drugs have been studied to reduce coughing during emergence.

Among others, the role of lidocaine given intravenously, topically, or intracuff has been studied. The use of intracuff alkalinized lidocaine has been proven effective to reduce the incidence of coughing during emergence of anesthesia.

Furthermore, there is some evidence supporting the administration of intravenous opioids prior to emergence of general anesthesia to reduce perioperative coughing, agitation and hemodynamic stimulation. However, depending on the type of opioids given, this may delay the emergence from anesthesia. The effect of a remifentanil infusion given in combination with isoflurane as the volatile agent has been shown to reduce the incidence of perioperative coughing without delaying the emergence of anesthesia. Bolus doses of remifentanil have also been proven effective to reduce the hemodynamic response to extubation.

The effect of these two modalities (alkalinized lidocaine and remifentanil) have never been compared. This study will assess their efficacy to prevent perioperative coughing after a desflurane-based anesthesia.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients aged 18-80 years
  • Physical status 1-3
  • Patients undergoing elective surgery under general anesthesia requiring oral endotracheal intubation (excluding head and neck surgery)
  • Expected duration of surgery of at least 1.5 hour.

排除标准

  • Current use of ACE inhibitor
  • Chronic cough
  • Asthma or severe pulmonary disease
  • Pulmonary tract infection
  • Anticipated difficult intubation
  • Current use of opioids
  • Current use of cough medicine
  • Contraindication to remifentanil, lidocaine
  • Pregnancy
  • Symptomatic cardiac, renal or hepatic disease

研究组 & 干预措施

Remifentanil 0.25 mcg/kg

Active Comparator

Administration of a bolus dose of intravenous remifentanil before emergence of a desflurane-based anesthesia

干预措施: Remifentanil (Drug)

Alkalinized lidocaine

Experimental

Administration of alkalinized lidocaine in the endotracheal tube cuff

干预措施: Alkalinized lidocaine (Drug)

结局指标

主要结局

Incidence of coughing during emergence and after extubation

时间窗: From emergence until 10 minutes after extubation

次要结局

  • Time to emergence(From the discontinuation of Desflurane until extubation)
  • Incidence of sore throat one hour after extubation(Assessed one hour after extubation)

研究者

发起方
Centre hospitalier de l'Université de Montréal (CHUM)
申办方类型
Other
责任方
Sponsor

研究点 (1)

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