Opioids and Esophageal Function

NCT ID: NCT01012960

Last Updated: 2011-12-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-01-31

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.

Conditions

Pharyngeal Dysfunction; Esophageal Dysfunction

Keywords

methylnaltrexone; upper esophageal sphincter; lower esophageal sphincter; high resolution solid state manometry; opioid induced pharyngeal and esophageal dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Placebo

Placebo= normal saline

Group Type: PLACEBO_COMPARATOR

methylnaltrexone

Intervention Type: DRUG

0,15 mg/kg sc ( subcutaneously)once per volunteer

methylnaltexone

peripheral opioid antagonist

Group Type: ACTIVE_COMPARATOR

methylnaltrexone

Intervention Type: DRUG

0,15 mg/kg sc ( subcutaneously)once per volunteer

Interventions

methylnaltrexone

0,15 mg/kg sc ( subcutaneously)once per volunteer

Intervention Type: DRUG

Other Intervention Names

Relistor

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer

INDUSTRY

Sponsor Role: collaborator

Region Örebro County

OTHER

Sponsor Role: lead

Responsible Party

Johanna Savilampi

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Magnus Wattwil, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Örebro

Locations

Department of Anaesthesiology, University Hospital Örebro

Örebro, , Sweden

University Hospital Örebro

Örebro, , Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 23713743 (View on PubMed)

Other Identifiers

JS001

Identifier Type: -

Identifier Source: org_study_id