drugset / Trial / NCT03283020

Opioid-Induced Swallowing Dysfunction - The Impact of Bolus Volume

NCT03283020

Phase 4 Unknown 20 enrolled Region Örebro County
RandomizedCrossoverDouble-blindBasic science

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.

Timeline

Start
2017-11-11
Primary completion
2018-04-01
Completion
2018-04-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Methylnaltrexone Other / unclassified 0.3 mg/kg Intravenous
Comparator Remifentanil Small molecule 3 ng/ml Intravenous

Indications