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临床试验/NCT01532466
NCT01532466已完成不适用

The Effect of Priming Intravenous Rocuronium on Fentanyl-Induced Coughing

Taichung Armed Forces General Hospital1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2011年3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
入组人数
260
试验地点
1
主要终点
Incidence of fentanyl-induced coughing

研究概览

简要总结

An intravenous bolus of fentanyl often induces a cough reflex. This study investigates whether priming with rocuronium can attenuate fentanyl-induced coughing effectively.

详细描述

Fentanyl is widely used for analgesia and anesthesia because of its rapid onset, its intense analgesic effect, and is associated with lessened cardiovascular depression and low histamine release. Although the cough reflex is usually transient and self-limiting, it should be avoided in situations such as elevated intracranial, intraocular, or intra-abdominal pressure, and unstable hemodynamics.

The cause of FIC is unclear. One hypothesis is that vocal cord spasms might induce coughing because of fentanyl-induced muscle rigidity and histamine release. Muscle relaxants are commonly used to treat this condition. This study hypothesizes that priming muscle relaxants could prevent or suppress FIC. This study investigates whether the muscle relaxant rocuronium attenuates FIC effectively.

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

  • 260 ASA I-II patients,
  • aged between 18 and 80 years, and undergoing various elective surgeries at Taichung Armed Forces General Hospital.

排除标准

  • a history of asthma,
  • chronic cough,
  • upper respiratory tract infection in the previous 2 weeks, and
  • medication containing angiotensin-converting enzyme inhibitors or anesthetic premedication.

研究组 & 干预措施

Rocuronium, fentanyl-induced cough, normal saline

Experimental

All patients were given oxygen via a face mask. The patients were then administered with the following medications intravenously: the rocuronium group received rocuronium 0.06 mg kg-1 30 s before the injection of an IV fentanyl bolus (1.5 mcg kg-1, within 2 s).

干预措施: Rocuronium (Drug)

结局指标

主要结局

Incidence of fentanyl-induced coughing

时间窗: 2 minutes

Following the fentanyl injection, another anesthetist who was blind to the pretreatment recorded the number of coughs for 1 min. The severity of coughing was graded as mild (1-2 times), moderate (3-5 times), or severe (\> 5 times) based on the number of coughs within the 1 min following the fentanyl injection. Assisted mask ventilation with oxygen was supplied if desaturation occurred (SpO2 \< 90%).

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Huei-Chi Horng, MD

Principal Investigator

Taichung Armed Forces General Hospital

研究点 (1)

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