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Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

NCT01495377 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 25

Last updated 2012-08-22

No results posted yet for this study

Summary

The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.

Conditions

  • Opioid Induced Swallowing Disorders

Interventions

DRUG

Remifentanil

Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)

DRUG

Placebo

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

DRUG

Technetium

37-40 MBq( effective dose 0,7 mSv) 99Tc albumin colloid in a volume of 6 ml, infusion velocity 0,1 ml/min via a transnasal catheter

DEVICE

Dynamometer (Jamar)

portable hydraulic hand dynamometer to assess grip strength.

Sponsors & Collaborators

  • Region Örebro County

    lead OTHER

Principal Investigators

  • magnus wattwil, MD, PhD · University Hospital in Örebro

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2012-01-31
Primary Completion
2012-05-31
Completion
2012-05-31

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 NCT01495377 on ClinicalTrials.gov