Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration
Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?
1 other identifier
interventional
25
1 country
2
Brief Summary
The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Jan 2012
Shorter than P25 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 9, 2011
CompletedFirst Posted
Study publicly available on registry
December 20, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedAugust 22, 2012
August 1, 2012
4 months
December 9, 2011
August 21, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Radioactivity evident in lungs imaged using a gamma camera
one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion
Secondary Outcomes (1)
Grip strength measured with Jamar dynamometer
volunteers are studied during two hours during which grip strength is measured three times
Study Arms (4)
Remifentanil
ACTIVE COMPARATORPlacebo
PLACEBO COMPARATORTechnetium
EXPERIMENTALDynamometer
EXPERIMENTALInterventions
Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)
Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
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
portable hydraulic hand dynamometer to assess grip strength.
Eligibility Criteria
You may qualify if:
- 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:
- Pharyngoesophageal dysfunction
- Anamnesis of pharyngoesophageal dysfunction
- Known history of cardiac, pulmonary or neurological disease
- Ongoing medication
- Allergies to or history of reaction to naloxone, remifentanil, fentanyl analogues or other ingredients
- History of reaction to products containing human albumine
- Pregnancy or breast feeding
- BMI \> 30
- Previous participation in a medical clinical trial where opioid has been used or have during last 30 days participated in any other medicinal clinical trial or in a trial where follow-up in not completed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital in Örebro
Örebro, 701 85, Sweden
Örebro University Hospital
Örebro, 70185, Sweden
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
magnus wattwil, MD, PhD
University Hospital in Örebro
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
December 9, 2011
First Posted
December 20, 2011
Study Start
January 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
August 22, 2012
Record last verified: 2012-08