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Opioid Effects on Swallowing and Esophageal Sphincter Pressure

NCT01191645 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 14

Last updated 2012-02-02

No results posted yet for this study

Summary

The purpose of this study is to determine whether a dopamine receptor antagonist metoclopramide can counteract opioid induced effects on esophageal motility and lower esophageal sphincter. The aim of this study is also to evaluate if the opioid antagonist naloxone reduces the opioid induced pharyngeal and esophageal dysfunction.

Conditions

  • Opioid Induced Pharyngeal and Esophageal Dysfunction

Interventions

DRUG

naloxone

Injection fluid, solution 0,4 mg/kg Bolus infusion 6ug/kg at one occasion Continuous infusion 0,1 ug/kg/minute during 50 min

DRUG

remifentanil

Powder for injection/ infusion fluid solution, 2 mg Infusion TCI 1ng/kg 10 min ( 0,05 ug/kg/min) Infusion TCI 2ng/kg 10 min ( 0.10 ug/kg/min) Infusion TCI 3ng/kg 20 min ( 0,15 ug/kg/min)

DRUG

Sodium Chloride

Infusion fluid, solution 9 mg/ml ( hydrogenic solution )

DRUG

metoclopramide

Injection fluid, solution 5 mg/mg Iv injection 0,2 mg/kg at one occasion

Sponsors & Collaborators

  • Region Örebro County

    lead OTHER

Principal Investigators

  • Magnus Wattwil, MD · University Hospital Örebro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2010-10-31
Primary Completion
2010-11-30
Completion
2010-11-30

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01191645 on ClinicalTrials.gov