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Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

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ClinicalTrials.gov Identifier: NCT01924234
Recruitment Status : Completed
First Posted : August 16, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
Johanna Savilampi, University Hospital Orebro

Brief Summary:
The purpose of the study is to determine whether remifentanil influence the pharyngeal phase of swallowing using using pressure and impedance recordings. The purpose is also to compare remifentanil to morphine and younger to elderly volunteers.

Condition or disease Intervention/treatment Phase
Pharyngeal Dysfunction Pharyngeal Swallowing Drug: Morphine Drug: Remifentanil Phase 4

Detailed Description:
Remifentanil and other opioids are widely used as anesthetic sedation during minor surgical procedures and as pain relief in postoperative patients when the patient is spontaneously breathing and the airway is not secured by endotracheal intubation. In a previous study (not yet published) we showed that remifentanil induce pulmonary aspiration in healthy volunteers and the aim of this study is to objectively determine weather remifentanil infusion in healthy volunteers influence the pharyngeal phase of swallowing. The purpose is also compare the effect of remifentanil to morphine and younger volunteers to elderly volunteers. To assess this question we are going to study 24 volunteers, 12 younger and 12 elderly, who are randomised to receive remifentanil infusion with target concentration 3 ng/ml during 30 minutes at one occasion and an injection of morphine (younger: 0.1 mg/kg, elderly 0.07 mg/kg) at the other. The volunteers are asked to swallow 10 ml normal saline several times both before and after opioid administration and pharyngeal motility is parallelly recorded using combined manometry and impedance catheter placed transnasally into to the pharyngo-esophageal segment. Any subjective swallowing difficulties are also recorded.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers
Study Start Date : August 2013
Primary Completion Date : December 2014
Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: morphine
Volunteers are given morphine injection
Drug: Morphine
Other Names:
  • ACT-code: N02AA01
  • Younger volunteers: injection 0.1 mg/kg
  • Elderly volunteers: injections 0.07 mg/kg
Active Comparator: remifentanil
Volunteers are given remifentanil infusion
Drug: Remifentanil
Other Names:
  • Ultiva
  • ATC-code: N01AH06
  • Powder for injection/ infusion fluid solution, 1 mg Infusion TCI 3 ng/ml 30 min ( 0,15 ug/kg/min)



Primary Outcome Measures :
  1. Pressure-Flow Variables measured by combined manometry and impedance system ( ManoScan 360) during pharyngeal swallowing [ Time Frame: up to 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection) ]

Secondary Outcome Measures :
  1. Subjective swallowing difficulties measured by 4-point scale [ Time Frame: Variables are measured before (baseline) and 15 min and 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 18-30 or 65 < 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
  • Known history of cardiac, pulmonary or neurological disease
  • Ongoing medication
  • Allergies to or history of reaction to remifentanil, fentanyl analogues or other ingredients
  • 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 complete.

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 ClinicalTrials.gov identifier (NCT number): NCT01924234


Locations
Sweden
Örebro University Hospital
Örebro, Sweden, 70185
Sponsors and Collaborators
Region Örebro County
Investigators
Principal Investigator: Johanna Savilampi, M.D Department of Anesthesiology and Intensive Care, Örebro University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Johanna Savilampi, M.D., University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01924234     History of Changes
Other Study ID Numbers: JS004
First Posted: August 16, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Johanna Savilampi, University Hospital Orebro:
Remifentanil
Pharyngeal dysfunction
Subjective swallowing difficulties
Pulmonary aspiration

Additional relevant MeSH terms:
Morphine
Remifentanil
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Hypnotics and Sedatives
Anesthetics, Intravenous
Anesthetics, General
Anesthetics