Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration
The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.
Opioid Induced Swallowing Disorders
Device: Dynamometer (Jamar)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?|
- Radioactivity evident in lungs imaged using a gamma camera [ Time Frame: one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion ] [ Designated as safety issue: No ]
- Grip strength measured with Jamar dynamometer [ Time Frame: volunteers are studied during two hours during which grip strength is measured three times ] [ Designated as safety issue: No ]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.
|Study Start Date:||January 2012|
|Study Completion Date:||May 2012|
|Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
|Active Comparator: Remifentanil||
Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)
|Placebo Comparator: Placebo||
Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
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
Device: Dynamometer (Jamar)
portable hydraulic hand dynamometer to assess grip strength.
Other Name: Jamar dynamometer
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01495377
|University Hospital in Örebro|
|Örebro, Sweden, 701 85|
|Örebro University Hospital|
|Örebro, Sweden, 70185|
|Study Chair:||magnus wattwil, MD, PhD||University Hospital in Örebro|