Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?
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
- 是
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
干预措施: Remifentanil (Drug)
Placebo
干预措施: Placebo (Drug)
Technetium
干预措施: Technetium (Drug)
Dynamometer
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
Johanna Savilampi
principal investigator
Region Örebro County
