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临床试验/NCT01489072
NCT01489072已完成不适用

Comparison of the Efficacy of Two Bolus Doses of 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 180 人开始时间: 2012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
发起方
入组人数
180
试验地点
1
主要终点
Incidence of coughing during emergence and the first ten minutes after extubation

研究概览

简要总结

This study is designed to compare the effects of two bolus doses of intravenous 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 a higher remifentanil bolus dose (0.5 mcg/kg) given prior to emergence of a desflurane-based anesthesia will reduce the incidence of perioperative coughing when compared to a lower dose of remifentanil (0.25 mcg/kg).

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.

Most patients will cough during emergence. Different techniques and drugs have been studied to reduce coughing during emergence.

There is some evidence supporting the administration of intravenous opioids prior to emergence of general anesthesia to reduce perioperative coughing, agitation and haemodynamic 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. The effect of a small bolus of remifentanil given prior to emergence to prevent perioperative coughing has yet to be studied.

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.

This study will compare the effects of two bolus doses of remifentanil (0.25 mcg/kg to 0.5 mcg/kg) when given prior to emergence 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
否

入选标准

  • •Patients aged 18-80 years
  • •Physical status 1-3
  • •Patients undergoing elective surgery under general anesthesia requiring endotracheal intubation (excluding head and neck surgery)

排除标准

  • •Current use of ACE inhibitors
  • •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
  • •Pregnancy
  • •Symptomatic cardiac, renal or hepatic disease

研究组 & 干预措施

Remifentanil 0.5 mcg/kg

Active Comparator

Administration of a bolus dose of remifentanil 0.5 mcg/kg before emergence of a desflurane-based anesthesia

干预措施: Remifentanil (Drug)

Remifentanil 0.25 mcg/kg

Experimental

Administration of a bolus dose of remifentanil 0.25 mcg/kg before emergence of a desflurane-based anesthesia

干预措施: Remifentanil (Drug)

结局指标

主要结局

Incidence of coughing during emergence and the first ten minutes after extubation

时间窗: From emergence until 10 minutes after extubation

次要结局

  • Time elapsed between the bolus dose of remifentanil and extubation(Assessed at emergence of general anesthesia)
  • 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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