Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

Region Örebro County

Status and phase: Completed; Phase 4

Conditions: Opioid Induced Swallowing Disorders

Treatments: Drug: Technetium; Drug: Remifentanil; Device: Dynamometer (Jamar); Drug: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT01495377

JS003

Details and patient eligibility

About

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

Full 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.

Enrollment: 25 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

---

25 participants in 4 patient groups, including a placebo group

Remifentanil

Active Comparator group

Treatment:

Drug: Remifentanil

Placebo

Placebo Comparator group

Treatment:

Drug: Placebo

Technetium

Experimental group

Treatment:

Drug: Technetium

Dynamometer

Experimental group

Treatment:

Device: Dynamometer (Jamar)