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临床试验/NCT01495377
NCT01495377已完成4 期

Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?

Region Örebro County2 个研究点 分布在 1 个国家目标入组 25 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
4 期
状态
已完成
发起方
入组人数
25
试验地点
2
主要终点
Radioactivity evident in lungs imaged using a gamma camera

研究概览

简要总结

The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.

详细描述

Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in icu-patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In these circumstances inability to clear the pharynx by swallowing may increase risk for aspiration.In a previous study ( not yet published) we showed that remifentanil induce subjective swallowing difficulties in healthy volunteers and the aim of this study is to determine weather remifentanil infusion in healthy non-intubated volunteers increase risk for pulmonary aspiration. To assess this question we are going to study 14 volunteers who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 60 minutes at one occasion and an equal amount of saline at the other. Radioactive Technetium colloid solution is parallelly infused through a pliable catheter transnasally. After remifentanil infusion is stopped the transnasal catheter is removed and the volunteer is asked to swallow water to clear the remaining radioactivity from upper gastrointestinal tract. Thereafter lung scanning with a gamma camera is performed. Through which mechanism remifentanil cause swallowing difficulties is not known.To determine weather remifentanil induce general muscle weakness in volunteers measurements of grip strength using Jamar dynamometer are performed before, during and 15 minutes after remifentanil infusion.

研究设计

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

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 18 - 40 year old healthy volunteers from both sexes.
  • Have signed and dated Informed Consent.
  • Willing and able to comply with the protocol for the duration of the trial.

排除标准

  • Pharyngoesophageal dysfunction
  • Anamnesis of pharyngoesophageal dysfunction
  • Known history of cardiac, pulmonary or neurological disease
  • Ongoing medication
  • Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or other ingredients
  • History of reaction to products containing human albumine
  • Pregnancy or breast feeding
  • BMI > 30
  • Previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not completed

研究组 & 干预措施

Remifentanil

Active Comparator

干预措施: Remifentanil (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

Technetium

Experimental

干预措施: Technetium (Drug)

Dynamometer

Experimental

干预措施: Dynamometer (Jamar) (Device)

结局指标

主要结局

Radioactivity evident in lungs imaged using a gamma camera

时间窗: one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion

次要结局

  • Grip strength measured with Jamar dynamometer(volunteers are studied during two hours during which grip strength is measured three times)

研究者

发起方
Region Örebro County
申办方类型
Other
责任方
Principal Investigator
主要研究者

Johanna Savilampi

principal investigator

Region Örebro County

研究点 (2)

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