Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

Phase 4

Completed

• Conditions: Opioid Induced Swallowing Disorders
• Interventions: Drug: Placebo; Device: Dynamometer (Jamar); Drug: Technetium; Drug: Remifentanil

• Registration Number: NCT01495377
• Lead Sponsor: Region Örebro County

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2011-12-09
• Study First Submitted QC: 2011-12-19
• Study First Posted: 2011-12-20
• Study Start: 2012-01
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-21
• Last Update Posted: 2012-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	-
Dynamometer	Dynamometer (Jamar)	-
Technetium	Technetium	-
Remifentanil	Remifentanil	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Grip strength measured with Jamar dynamometer	volunteers are studied during two hours during which grip strength is measured three times	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.

Trial Locations

Locations (2)

Örebro University Hospital; 🇸🇪 Örebro, Sweden

University Hospital in Örebro; 🇸🇪 Örebro, Sweden