Opioid Induced Swallowing Difficulties and Risk for Pulmonary Aspiration

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Johanna Savilampi, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01495377
First received: December 9, 2011
Last updated: August 21, 2012
Last verified: August 2012
  Purpose

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


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Does Opioid Induced Swallowing Difficulty Lead to Elevated Risk for Pulmonary Aspiration?

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Grip strength measured with Jamar dynamometer [ Time Frame: volunteers are studied during two hours during which grip strength is measured three times ] [ Designated as safety issue: No ]
    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.


Enrollment: 25
Study Start Date: January 2012
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01495377

Locations
Sweden
University Hospital in Örebro
Örebro, Sweden, 701 85
Örebro University Hospital
Örebro, Sweden, 70185
Sponsors and Collaborators
University Hospital Orebro
Investigators
Study Chair: magnus wattwil, MD, PhD University Hospital in Örebro
  More Information

No publications provided

Responsible Party: Johanna Savilampi, principal investigator, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01495377     History of Changes
Other Study ID Numbers: JS003
Study First Received: December 9, 2011
Last Updated: August 21, 2012
Health Authority: Sweden: Swedish National Council on Medical Ethics

Keywords provided by University Hospital Orebro:
swallowing difficulties
remifentanil
pulmonary aspiration
scintigraphy

Additional relevant MeSH terms:
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics

ClinicalTrials.gov processed this record on October 16, 2014