Opioids and Esophageal Function

Pharyngeal Dysfunction Clinical Trial

Official title:

Is the Opioid-induced Pharyngeal and Esophageal Dysfunction Peripherally or Central Mediated?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01012960
• Other study ID #: JS001
• Status: Completed
• Phase: Phase 4
• First received: November 10, 2009
• Last updated: December 8, 2011
• Start date: November 2009
• Est. completion date: January 2010

Study information

• Verified date: December 2011
• Source: University Hospital Orebro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Esophageal Diseases
• Esophageal Dysfunction
• Pharyngeal Dysfunction

Intervention

Drug:
• methylnaltrexone
0,15 mg/kg sc ( subcutaneously)once per volunteer

Locations

Country	Name	City	State
Sweden	Department of Anaesthesiology, University Hospital Örebro	Örebro
Sweden	University Hospital Örebro	Örebro

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital Orebro	Wyeth is now a wholly owned subsidiary of Pfizer

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Does methylnaltrexone influence the upper and lower esophageal sphincter pressure and the swallowing function following opioid administration?		6 hours per volunteer	No
Secondary	Does methylnaltrexone influence the experience of swallowing function following opioid administration?		6 hours per volunteer	No