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Opioid-Induced Swallowing Dysfunction - The Impact of Bolus Volume

NCT03283020 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2017-12-12

No results posted yet for this study

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.

Conditions

  • Pharyngeal Dysfunction
  • Pharyngeal Swallowing

Interventions

DRUG

RemifentanilMNTX

Remifentanil infusion TCI 3 ng/ml, Methylnaltrexone injection 0.3 mg/kg

DRUG

PlaceboMNTX

Placebo (NaCl 0.9%) TCI infusion, Methylnaltrexone injection 0.3 mg/kg

Sponsors & Collaborators

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Johanna Savilampi, MD, PhD · University hospital in Örebro

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

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

Countries

  • Sweden

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03283020 on ClinicalTrials.gov