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临床试验/NCT01924234
NCT01924234已完成4 期

Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

Region Örebro County1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2013年8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
18
试验地点
1
主要终点
Pressure-Flow Variables measured by combined manometry and impedance system ( ManoScan 360) during pharyngeal swallowing

研究概览

简要总结

The purpose of the study is to determine whether remifentanil influence the pharyngeal phase of swallowing using using pressure and impedance recordings. The purpose is also to compare remifentanil to morphine and younger to elderly volunteers.

详细描述

Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in postoperative patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In a previous study (not yet published) we showed that remifentanil induce pulmonary aspiration in healthy volunteers and the aim of this study is to objectively determine weather remifentanil infusion in healthy volunteers influence the pharyngeal phase of swallowing. The purpose is also compare the effect of remifentanil to morphine and younger volunteers to elderly volunteers. To assess this question we are going to study 24 volunteers, 12 younger and 12 elderly, who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 30 minutes at one occasion and an injection of morphine (younger: 0.1 mg/kg, elderly 0.07 mg/kg) at the other. The volunteers are asked to swallow 10 ml normal saline several times both before and after opioid administration and pharyngeal motility is parallelly recorded using combined manometry and impedance catheter placed transnasally into to the pharyngo-esophageal segment. Any subjective swallowing difficulties are also recorded.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18-30 or 65 < 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
  • Known history of cardiac, pulmonary or neurological disease
  • Ongoing medication
  • Allergies to or history of reaction to remifentanil, fentanyl analogues or other ingredients
  • 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 complete.

研究组 & 干预措施

morphine

Active Comparator

Volunteers are given morphine injection

干预措施: Morphine (Drug)

remifentanil

Active Comparator

Volunteers are given remifentanil infusion

干预措施: Remifentanil (Drug)

结局指标

主要结局

Pressure-Flow Variables measured by combined manometry and impedance system ( ManoScan 360) during pharyngeal swallowing

时间窗: up to 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection)

次要结局

  • Subjective swallowing difficulties measured by 4-point scale(Variables are measured before (baseline) and 15 min and 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection))

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

M.D.

Region Örebro County

研究点 (1)

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