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Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01495377
Recruitment Status : Completed
First Posted : December 20, 2011
Last Update Posted : August 22, 2012
Information provided by (Responsible Party):
Johanna Savilampi, Region Örebro County

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

Condition or disease Intervention/treatment Phase
Opioid Induced Swallowing Disorders Drug: Remifentanil Drug: Placebo Drug: Technetium Device: Dynamometer (Jamar) Phase 4

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 not secured by endotracheal intubation. In these circumstances inability to clear the pharynx by swallowing may increase risk for aspiration.In a previous study ( not yet published) we showed that remifentanil induce subjective swallowing difficulties in healthy volunteers and the aim of this study is to determine weather remifentanil infusion in healthy non-intubated volunteers increase risk for pulmonary aspiration. To assess this question we are going to study 14 volunteers who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 60 minutes at one occasion and an equal amount of saline at the other. Radioactive Technetium colloid solution is parallelly infused through a pliable catheter transnasally. After remifentanil infusion is stopped the transnasal catheter is removed and the volunteer is asked to swallow water to clear the remaining radioactivity from upper gastrointestinal tract. Thereafter lung scanning with a gamma camera is performed. Through which mechanism remifentanil cause swallowing difficulties is not known.To determine weather remifentanil induce general muscle weakness in volunteers measurements of grip strength using Jamar dynamometer are performed before, during and 15 minutes after remifentanil infusion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?
Study Start Date : January 2012
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Remifentanil Drug: Remifentanil
Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 60 min ( 0,15 ug/kg/min)
Other Names:
  • Ultiva
  • ATC-code: N01AH06

Placebo Comparator: Placebo Drug: Placebo
Infusion fluid, solution 9 mg/ml ( hydrogenic solution )
Other Names:
  • Saline
  • ACT-code: B05XA03

Experimental: Technetium 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
Other Names:
  • Nanocol
  • ACT-code: V09DB01

Experimental: Dynamometer Device: Dynamometer (Jamar)
portable hydraulic hand dynamometer to assess grip strength.
Other Name: Jamar dynamometer

Primary Outcome Measures :
  1. Radioactivity evident in lungs imaged using a gamma camera [ Time Frame: one study occasion takes two hours and a gamma camera scan is taken in the end of the occasion ]

Secondary Outcome Measures :
  1. Grip strength measured with Jamar dynamometer [ Time Frame: volunteers are studied during two hours during which grip strength is measured three times ]
    Jamar dynamometer is positioned in the dominant hand att maximal grip strength contraction is taken three times, the mean value is used for the analysis.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • 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 Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01495377

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University Hospital in Örebro
Örebro, Sweden, 701 85
Örebro University Hospital
Örebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
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Study Chair: magnus wattwil, MD, PhD University Hospital in Örebro
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Responsible Party: Johanna Savilampi, principal investigator, Region Örebro County Identifier: NCT01495377    
Other Study ID Numbers: JS003
First Posted: December 20, 2011    Key Record Dates
Last Update Posted: August 22, 2012
Last Verified: August 2012
Keywords provided by Johanna Savilampi, Region Örebro County:
swallowing difficulties
pulmonary aspiration
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Analgesics, Opioid
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents