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Opioids and Esophageal Function

Primary Purpose

Pharyngeal Dysfunction, Esophageal Dysfunction

Status
Completed
Phase
Phase 4
Locations
Sweden
Study Type
Interventional
Intervention
methylnaltrexone
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pharyngeal Dysfunction focused on measuring methylnaltrexone, upper esophageal sphincter, lower esophageal sphincter, high resolution solid state manometry, opioid induced pharyngeal and esophageal dysfunction

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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 Criteria:

  • anamnesis of pharyngoesophageal dysfunction.
  • known or history of cardiac, pulmonary or neurological disease.
  • ongoing medication.
  • allergies to or history of reaction to methylnaltrexone, remifentanil or fentanyl analogues.
  • pregnancy or breast feeding.
  • participation in another clinical medicinal trial during the last 30 days or where follow-up is not completed.

Sites / Locations

  • Department of Anaesthesiology, University Hospital Örebro
  • University Hospital Örebro

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

methylnaltexone

Arm Description

Placebo= normal saline

peripheral opioid antagonist

Outcomes

Primary Outcome Measures

Does methylnaltrexone influence the upper and lower esophageal sphincter pressure and the swallowing function following opioid administration?

Secondary Outcome Measures

Does methylnaltrexone influence the experience of swallowing function following opioid administration?

Full Information

First Posted
November 10, 2009
Last Updated
December 8, 2011
Sponsor
Region Örebro County
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT01012960
Brief Title
Opioids and Esophageal Function
Official Title
Is the Opioid-induced Pharyngeal and Esophageal Dysfunction Peripherally or Central Mediated?
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
January 2010 (Actual)
Study Completion Date
January 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County
Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to evaluate if opioid-induced effects on the pharynx and esophagus is centrally or peripherally mediated.
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 contributes to an increased risk of regurgitation and aspiration during anaesthesia induction and in the postoperative period, when the patient is treated with opioids for pain relief. The effects of opioid antagonists on the opioid induced pharyngeal dysfunction and lower esophageal sphincter pressure are unknown. Therefore it is of great clinical value to evaluate if these negative effects are reversed by peripheral opioid antagonist, methylnaltrexone. Methylnaltrexone is one of the newer agents of peripherally acting opioid antagonists that act to reverse some of the side effects of opioid drugs, such as constipation, without affecting analgesia. If the opioid induced pharyngeal and esophageal dysfunction and reduction of the lower esophageal sphincter pressure is peripherally induced or mediated via peripheral opioid receptors, methylnaltrexone might reverse these effects and thereby reduce postoperative morbidity by reducing pulmonary complications. On the other hand, if the dysfunction is centrally induced and not mediated via peripheral opioid receptors there is no effect of methylnaltrexone. The pharyngeal and esophageal motility/function can be registered in an easy and objective way with the high resolution manometry, ManoScan 360. ManoScan 360 is an equipment with 36 sensors at 1 cm spacing with 12 tip transducers at every sensor. The 36 closely spaced sensors automatically capture all relevant motor function from the pharynx to the stomach. The system collects reliable and consistent data records with improved diagnostic accuracy, and the data are analyzed using ManoView analyzes software. ManoScan 360 has a CE mark approval and has been used at Örebro University Hospital during the last two years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pharyngeal Dysfunction, Esophageal Dysfunction
Keywords
methylnaltrexone, upper esophageal sphincter, lower esophageal sphincter, high resolution solid state manometry, opioid induced pharyngeal and esophageal dysfunction

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo= normal saline
Arm Title
methylnaltexone
Arm Type
Active Comparator
Arm Description
peripheral opioid antagonist
Intervention Type
Drug
Intervention Name(s)
methylnaltrexone
Other Intervention Name(s)
Relistor
Intervention Description
0,15 mg/kg sc ( subcutaneously)once per volunteer
Primary Outcome Measure Information:
Title
Does methylnaltrexone influence the upper and lower esophageal sphincter pressure and the swallowing function following opioid administration?
Time Frame
6 hours per volunteer
Secondary Outcome Measure Information:
Title
Does methylnaltrexone influence the experience of swallowing function following opioid administration?
Time Frame
6 hours per volunteer

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Criteria: anamnesis of pharyngoesophageal dysfunction. known or history of cardiac, pulmonary or neurological disease. ongoing medication. allergies to or history of reaction to methylnaltrexone, remifentanil or fentanyl analogues. pregnancy or breast feeding. participation in another clinical medicinal trial during the last 30 days or where follow-up is not completed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Magnus Wattwil, MD
Organizational Affiliation
University Hospital Örebro
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Anaesthesiology, University Hospital Örebro
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden
Facility Name
University Hospital Örebro
City
Örebro
ZIP/Postal Code
701 85
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
23713743
Citation
Savilampi J, Ahlstrand R, Magnuson A, Wattwil M. Effects of remifentanil on the esophagogastric junction and swallowing. Acta Anaesthesiol Scand. 2013 Sep;57(8):1002-9. doi: 10.1111/aas.12134. Epub 2013 May 29.
Results Reference
derived

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Opioids and Esophageal Function

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