Opioid-Induced Swallowing Dysfunction - The Impact of Bolus Volume

• Status: Unknown status
• Trial end date: 2018-04-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of the study is to evaluate the impact of different bolus volumes and viscosity on remifentanil-induced swallowing dysfunction in healthy volunteers.Hence, whether swallowing tasks can be done safer during sedation by altering bolus volumes and viscosities will be revealed. Furthermore, the study will clarify underlying mechanisms (central vs. peripheral effects) of remifentanil-induced swallowing dysfunction. If methylnaltrexone reverses the remifentanil-induced effects on swallowing, this would suggest a dominant peripherally mediated mechanism.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Region Örebro County
• Treatments: Methylnaltrexone; Naltrexone; Remifentanil

Criteria

Inclusion Criteria:

1. ≥ 18 - ≤ 40 year old healthy volunteers from both sexes.

2. Have signed and dated Informed Consent.

3. Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria:

1. Anamnesis of pharyngoesophageal dysfunction.

2. Known or history of gastrointestinal, severe cardiac, pulmonary or neurological disease

3. Ongoing medication that may affect upper gastrointestinal tract, larynx or lower airway.

4. Allergies to or history of reaction to remifentanil, fentanyl analogues or dexmedetomidine.

5. Pregnancy or breast feeding

6. BMI > 30

7. Smoking

8. Previous participation in a medicinal clinical trial during the last year where an opioid has been used or have during the last 30 days participated in any other medicinal clinical trial or in a trial where follow-up is not completed.