Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration
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Purpose
The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.
| Condition | Intervention | Phase |
|---|---|---|
|
Opioid Induced Swallowing Disorders |
Drug: Remifentanil Drug: Placebo Drug: Technetium Device: Dynamometer (Jamar) |
Phase 4 |
| Study Type: | Interventional |
| 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.
| Enrollment: | 25 |
| Study Start Date: | January 2012 |
| Study Completion Date: | May 2012 |
| Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Active Comparator: Remifentanil |
Drug: Remifentanil
Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)
Other Names:
|
| Placebo Comparator: Placebo |
Drug: Placebo
Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
Other Names:
|
| Experimental: Technetium |
Drug: Technetium
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
Other Names:
|
| Experimental: Dynamometer |
Device: Dynamometer (Jamar)
portable hydraulic hand dynamometer to assess grip strength.
Other Name: Jamar dynamometer
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years to 40 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations| Sweden | |
| University Hospital in Örebro | |
| Örebro, Sweden, 701 85 | |
| Örebro University Hospital | |
| Örebro, Sweden, 70185 | |
| Study Chair: | magnus wattwil, MD, PhD | University Hospital in Örebro |
More Information
No publications provided
| Responsible Party: | Johanna Savilampi, principal investigator, University Hospital Orebro |
| ClinicalTrials.gov Identifier: | NCT01495377 History of Changes |
| Other Study ID Numbers: | JS003 |
| Study First Received: | December 9, 2011 |
| Last Updated: | August 21, 2012 |
| Health Authority: | Sweden: Swedish National Council on Medical Ethics |
Keywords provided by University Hospital Orebro:
|
swallowing difficulties remifentanil pulmonary aspiration scintigraphy |
Additional relevant MeSH terms:
|
Deglutition Disorders Esophageal Diseases Gastrointestinal Diseases Digestive System Diseases Pharyngeal Diseases Otorhinolaryngologic Diseases Remifentanil Analgesics, Opioid Analgesics Sensory System Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions Central Nervous System Agents Therapeutic Uses Central Nervous System Depressants Hypnotics and Sedatives Anesthetics, Intravenous Anesthetics, General Anesthetics |
ClinicalTrials.gov processed this record on May 16, 2013