Status:

UNKNOWN

Opioid-Induced Swallowing Dysfunction - The Impact of Bolus Volume

Lead Sponsor:

Region Örebro County

Conditions:

Pharyngeal Dysfunction

Pharyngeal Swallowing

Eligibility:

All Genders

18-40 years

Phase:

PHASE4

Brief 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 ...

Detailed Description

Monitored anesthesia care (MAC) is commonly applied in modern perioperative care and means that minor surgical procedures are accomplished in awake patients using local anesthesia and light sedation. ...

Eligibility Criteria

Inclusion

  • ≥ 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

  • Anamnesis of pharyngoesophageal dysfunction.
  • Known or history of gastrointestinal, severe cardiac, pulmonary or neurological disease
  • Ongoing medication that may affect upper gastrointestinal tract, larynx or lower airway.
  • Allergies to or history of reaction to remifentanil, fentanyl analogues or dexmedetomidine.
  • Pregnancy or breast feeding
  • BMI \> 30
  • Smoking
  • 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.

Key Trial Info

Start Date :

November 11 2017

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

April 1 2018

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT03283020

Start Date

November 11 2017

End Date

April 1 2018

Last Update

December 12 2017

Active Locations (1)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (1 locations)

1

Department of Anaesthesiology and Intensive Care, Örebro University Hospital

Örebro, Sweden, 70185