Status:

COMPLETED

Opioid Effects on Swallowing and Esophageal Sphincter Pressure

Lead Sponsor:

Region Örebro County

Conditions:

Opioid Induced Pharyngeal and Esophageal Dysfunction

Eligibility:

All Genders

18-40 years

Phase:

PHASE4

Brief Summary

The purpose of this study is to determine whether a dopamine receptor antagonist metoclopramide can counteract opioid induced effects on esophageal motility and lower esophageal sphincter. The aim of ...

Detailed Description

Opioids induce pharyngeal and esophageal dysfunction and reduce the lower esophageal sphincter (LES) pressure, and thereby decreases the barrier pressure between the stomach and esophagus. This contri...

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 history of cardiac, pulmonary or neurological disease
  • Ongoing medication
  • Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or metoclopramide
  • 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.

Key Trial Info

Start Date :

October 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

November 1 2010

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT01191645

Start Date

October 1 2010

End Date

November 1 2010

Last Update

February 2 2012

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Örebro University Hospital

Örebro, Sweden, 70185