Esophageal Motility Disorders
Conditions
Keywords
codeine, Esophageal motility, Pharyngeal motility
Brief summary
Opioids act on opioid receptors located in the brain as well as in the gastrointestinal (GI) tract to induce changes in motility. A variety of studies have linked chronic opioid use with changes in intestinal and to a lesser extent esophageal motility. Less is known about acute administration effects on distal esophageal motility and LES and even less with respect to proximal esophagus, UES and pharynx. Codeine, an opioid receptor agonist, by acting both centrally as well as in the periphery may induce changes in parts of the GI tract implicated in deglutition. Therefore, to evaluate the hypothesis the researchers will study motility patterns in the pharynx, UES, proximal and distal esophagus and LES in 22 healthy volunteers receiving placebo or codeine (60 mg) in a double-blind randomized cross-over controlled fashion. Motility patterns will be studied using state-of-the-art criteria and analytic tools (Chicago 3.0, AIMPlot analysis).
Interventions
30 mL of codeine phosphate 10mg/5mL
DRUGSiripus simplex
Sugar syrup
Sponsors
Universitaire Ziekenhuizen KU Leuven
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
Double-blind, preparation and administration of codeine or placebo conducted by an independent researcher.
Intervention model description
Double-blind, placebo-controlled, randomized, cross-over study in healthy volunteers
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
* Healthy volunteers aged between 18-60 years old * Written informed consent
Exclusion criteria
* No chronic disease/medication * No GI symptoms * Not pregnant or breast-feeding * No history of head/neck surgery * Not allergic to codeine
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in distal contractile integral | 1 week | The difference in distal contractile integral between the codeine and placebo condition |
| Difference in integrated relaxation pressure | 1 week | The difference in integrated relaxation pressure between the codeine and placebo condition |
| Difference in distal latency | 1 week | The difference in distal latency between the codeine and placebo condition. |
| Difference in pressure flow | 1 week | The difference in pressure flow between the codeine and placebo condition |
Countries
Belgium
Outcome results
None listed