Opioids and Esophageal Function

This study has been completed.
Sponsor:
Collaborator:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Johanna Savilampi, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01012960
First received: November 10, 2009
Last updated: December 8, 2011
Last verified: December 2011
  Purpose

The purpose of this study is to evaluate if opioid-induced effects on the pharynx and esophagus is centrally or peripherally mediated.


Condition Intervention Phase
Pharyngeal Dysfunction
Esophageal Dysfunction
Drug: methylnaltrexone
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Is the Opioid-induced Pharyngeal and Esophageal Dysfunction Peripherally or Central Mediated?

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • Does methylnaltrexone influence the upper and lower esophageal sphincter pressure and the swallowing function following opioid administration? [ Time Frame: 6 hours per volunteer ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Does methylnaltrexone influence the experience of swallowing function following opioid administration? [ Time Frame: 6 hours per volunteer ] [ Designated as safety issue: No ]

Enrollment: 13
Study Start Date: November 2009
Study Completion Date: January 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Placebo
Placebo= normal saline
Drug: methylnaltrexone
0,15 mg/kg sc ( subcutaneously)once per volunteer
Other Name: Relistor
Active Comparator: methylnaltexone
peripheral opioid antagonist
Drug: methylnaltrexone
0,15 mg/kg sc ( subcutaneously)once per volunteer
Other Name: Relistor

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01012960

Locations
Sweden
University Hospital Örebro
Örebro, Sweden, 701 85
Department of Anaesthesiology, University Hospital Örebro
Örebro, Sweden, 701 85
Sponsors and Collaborators
University Hospital Orebro
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Principal Investigator: Magnus Wattwil, MD University Hospital Örebro
  More Information

No publications provided by University Hospital Orebro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johanna Savilampi, MD, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01012960     History of Changes
Other Study ID Numbers: JS001
Study First Received: November 10, 2009
Last Updated: December 8, 2011
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by University Hospital Orebro:
methylnaltrexone
upper esophageal sphincter
lower esophageal sphincter
high resolution solid state manometry
opioid induced pharyngeal and esophageal dysfunction

Additional relevant MeSH terms:
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Methylnaltrexone
Naltrexone
Analgesics, Opioid
Narcotic Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Narcotics
Central Nervous System Depressants
Analgesics

ClinicalTrials.gov processed this record on September 15, 2014