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临床试验/NCT01365923
NCT01365923已完成4 期

Comparison of Dexmedetomidin and Remifentanil for the Effect on Airway Reflex and Hemodynamic Response During Emergence in Patients Undergoing Craniotomy

Yonsei University1 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2011年5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
入组人数
74
试验地点
1
主要终点
cough incidence

研究概览

简要总结

During recovery from general anesthesia the stimuli of endotracheal tube lead to the coughing, hypertension, tachycardia, which can cause a serious complication. Especially the postoperative course of patients emerging from general anesthesia after intracranial surgery is frequently complicated by the occurrence of hypertension and coughing event.

It has been demonstrated that opioid, intravenous or topical lidocaine administration can attenuate the coughing reflex. Administered the opioid before emergence, it is effective to prevent cough reflex but the recovery is delayed, it was difficult to predict emergence.

However, remifentanil is an opioid widely used because of rapid context-sensitive half-life, target-controled infusion method to adequately maintain the effect site concentration could help to predict the recovery time to the alert state from the general anesthesia. It is considered proper method of continuous infusion of remifentanil for reducing emergence cough.

Dexmedetomidine , a potent alpha adrenoceptor agonist which dose-dependently reduces arterial blood pressure and heart rate, decreases the hemodynamic and and catecholamine response to intubation and extubation. It is thus theologically appropriate for reducing airway and circulatory reflexes during emergence from anesthesia.

In this study, the investigators used bolus dexmedetomidine immediately before extubation, and compared the effects on coughing, hemodynamic response and recovery profile to a continuous infusion 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
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • SA I~II, 2.aged between 20 and 70 year, 4.general anesthesia for craniectomy

排除标准

  • signs of an anatomical or functional abnormality in upper airway
  • URI or sore throat for recent 2 weeks
  • Congestive heart failure, Sinus Bradycardia(<50 BPM), Uncontrolled hypertension
  • Chronic obstructive lung disease, bronchial asthma

研究组 & 干预措施

Remifentanil group

Active Comparator

Remifentanil group : remifentanil effect site-TCI 2-4ng/ml

干预措施: remifentanil (Drug)

Dexmedetimidine group

Active Comparator

Dexmedetomidine group: remifentanil effect site-TCI 2-4ng/ml + dexmedetomidine 0.5mcg/kg

干预措施: dexmedetomidine with remifentanil (Drug)

结局指标

主要结局

cough incidence

时间窗: 1 minute after extubation

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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