Status:
COMPLETED
Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration
Lead Sponsor:
Region Örebro County
Conditions:
Opioid Induced Swallowing Disorders
Eligibility:
All Genders
18-40 years
Phase:
PHASE4
Brief Summary
The purpose of this study is to determine weather remifentanil induced swallowing difficulties increase risk for pulmonary aspiration.
Detailed Description
Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in icu-patients when the patient is spontaneously breathing and the airway is ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT01495377
Start Date
January 1 2012
End Date
May 1 2012
Last Update
August 22 2012
Active Locations (2)
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1
University Hospital in Örebro
Örebro, Sweden, 701 85
2
Örebro University Hospital
Örebro, Sweden, 70185