Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

Conditions
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Pharyngeal Dysfunction, Pharyngeal Swallowing

Intervention / Treatment
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* Drug: Morphine
* Drug: Remifentanil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: morphine<br>Volunteers are given morphine injection | Drug: Morphine<br> <br> * Other names: Elderly volunteers: injections 0.07 mg/kg;|
| Active Comparator: remifentanil<br>Volunteers are given remifentanil infusion | Drug: Remifentanil<br> <br> * Other names: Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 30 min ( 0,15 ug/kg/min);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure-Flow Variables measured by combined manometry and impedance system ( ManoScan 360) during pharyngeal swallowing |  | up to 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Remifentanil, Pharyngeal dysfunction, Subjective swallowing difficulties, Pulmonary aspiration