Opioid-Induced Swallowing Dysfunction - The Impact of Bolus Volume

NCT03283020 | Unknown Phase 4 DMC

• 1 other identifier: JS006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to evaluate the impact of different bolus volumes and viscosity on remifentanil-induced swallowing dysfunction in healthy volunteers.Hence, whether swallowing tasks can be done safer during sedation by altering bolus volumes and viscosities will be revealed. Furthermore, the study will clarify underlying mechanisms (central vs. peripheral effects) of remifentanil-induced swallowing dysfunction. If methylnaltrexone reverses the remifentanil-induced effects on swallowing, this would suggest a dominant peripherally mediated mechanism.

Conditions

Pharyngeal Dysfunction; Pharyngeal Swallowing

Keywords

Remifentanil; Methylnaltrexone; Pharyngeal dysfunction; Anesthetic sedation

Outcome Measures

Primary Outcomes (1)

• Pressure Flow pharyngeal variables, 10 ml vs 20 ml bolus

  Difference in pharyngeal pressure flow variables during remifentanil exposure between bolus volumes of 10 ml and 20 ml compared to placebo.

  Up to 60 minutes

Secondary Outcomes (7)

• Pressure Flow pharyngeal variables, liquid vs semisolid bolus

  Up to 60 minutes

• Pressure Flow pharyngeal variables, remifentanil before vs after methylnaltrexone

  Up to 60 minutes

• Pressure Flow pharyngeal variables, placebo before vs after methylnaltrexone

  Up to 60 minutes

• Pressure Flow esophageal motility variables, 10 ml vs 20 ml bolus

  Up to 60 minutes

• Pressure Flow esophageal motility variables, liquid vs semisolid bolus

  Up to 60 minutes

Study Arms (2)

RemifentanilMNTX

ACTIVE COMPARATOR

Volunteers are given an intravenous infusion with remifentanil, with an effect-site target concentration of 3 ng/ml via a target-controlled infusion (TCI) pump. After a series of swallowing tests an intravenous injection of methylnaltrexone of 0,3 mg/kg is given.

Drug: RemifentanilMNTX

PlaceboMNTX

ACTIVE COMPARATOR

Volunteers are given an intravenous infusion with saline 0,9%. After a series of swallowing tests an intravenous injection of methylnaltrexone of 0,3 mg/kg is given.

Drug: PlaceboMNTX

Interventions

RemifentanilMNTX DRUG

Remifentanil infusion TCI 3 ng/ml, Methylnaltrexone injection 0.3 mg/kg

Also known as: Methylnaltrexone, Remifentanil, Relistor, Ultiva

RemifentanilMNTX

PlaceboMNTX DRUG

Placebo (NaCl 0.9%) TCI infusion, Methylnaltrexone injection 0.3 mg/kg

Also known as: Sodium Chloride 0.9%, Methylnaltrexone, Relistor

PlaceboMNTX

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ≥ 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.

You may not qualify if:

• Anamnesis of pharyngoesophageal dysfunction.
• Known or history of gastrointestinal, severe cardiac, pulmonary or neurological disease
• Ongoing medication that may affect upper gastrointestinal tract, larynx or lower airway.
• Allergies to or history of reaction to remifentanil, fentanyl analogues or dexmedetomidine.
• Pregnancy or breast feeding
• BMI \> 30
• Smoking
• Previous participation in a medicinal clinical trial during the last year where an opioid has been used or have during the last 30 days participated in any other medicinal clinical trial or in a trial where follow-up is not completed.

Sponsors & Collaborators

• Region Örebro County: lead

Study Sites (1)

Department of Anaesthesiology and Intensive Care, Örebro University Hospital

Örebro, 70185, Sweden

RECRUITING

MeSH Terms

Interventions

methylnaltrexone; Remifentanil; Sodium Chloride

Intervention Hierarchy (Ancestors)

Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Johanna Savilampi, MD, PhD

  University hospital in Örebro

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Johanna Savilampi, MD, PhD

CONTACT

+46196020266; johanna.savilampi@regionorebrolan.se

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: September 12, 2017
• First Posted: September 14, 2017
• Study Start: November 11, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: December 12, 2017

Record last verified: 2017-12

Locations

SE (1)