Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

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

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 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.

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

Conditions
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Opioid Induced Swallowing Disorders

Intervention / Treatment
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* Drug: Remifentanil
* Drug: Placebo
* Drug: Technetium
* Device: Dynamometer (Jamar)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Remifentanil<br> | Drug: Remifentanil<br>* Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)<br>* Other names: ATC-code: N01AH06;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Infusion fluid, solution 9 mg/ml ( hydrogenic solution )<br>* Other names: ACT-code: B05XA03;|
| Experimental: Technetium<br> | Drug: Technetium<br>* 37-40 MBq( effective dose 0,7 mSv) 99Tc albumin colloid in a volume of 6 ml, infusion velocity 0,1 ml/min via a transnasal catheter<br>* Other names: ACT-code: V09DB01;|
| Experimental: Dynamometer<br> | Device: Dynamometer (Jamar)<br>* portable hydraulic hand dynamometer to assess grip strength.<br>* Other names: Jamar dynamometer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radioactivity evident in lungs imaged using a gamma camera |  | one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grip strength measured with Jamar dynamometer | Jamar dynamometer is positioned in the dominant hand att maximal grip strength contraction is taken three times, the mean value is used for the analysis. | volunteers are studied during two hours during which grip strength is measured three times | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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swallowing difficulties, remifentanil, pulmonary aspiration, scintigraphy