Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

Opioid Induced Swallowing Disorders Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01495377
• Other study ID #: JS003
• Status: Completed
• Phase: Phase 4
• First received: December 9, 2011
• Last updated: August 21, 2012
• Start date: January 2012
• Est. completion date: May 2012

Study information

• Verified date: August 2012
• Source: University Hospital Orebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Deglutition Disorders
• Opioid Induced Swallowing Disorders

Intervention

Drug:
• Remifentanil
Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)
• Placebo
Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
• 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

Device:
• Dynamometer (Jamar)
portable hydraulic hand dynamometer to assess grip strength.

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro
Sweden	University Hospital in Örebro	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital Orebro

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No