Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by University Hospital Orebro
Sponsor:
Information provided by (Responsible Party):
Johanna Savilampi, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01924234
First received: August 12, 2013
Last updated: May 2, 2014
Last verified: August 2013
  Purpose

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 Intervention Phase
Pharyngeal Dysfunction
Pharyngeal Swallowing
Drug: Morphine
Drug: Remifentanil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
Official Title: Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

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

Secondary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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)

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
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.
  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: NCT01924234

Contacts
Contact: Johanna Savilampi, M.D +46 19 6020266 johannasavilampi@orebroll.se

Locations
Sweden
Örebro University Hospital Recruiting
Örebro, Sweden, 70185
Contact: Johanna Savilampi, M.D    +46196020266    johanna.savilampi@orebroll.se   
Principal Investigator: Johanna Savilampi, M.D         
Sponsors and Collaborators
University Hospital Orebro
Investigators
Principal Investigator: Johanna Savilampi, M.D Department of Anesthesiology and Intensive Care, Örebro University Hospital
  More Information

No publications provided

Responsible Party: Johanna Savilampi, M.D., University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01924234     History of Changes
Other Study ID Numbers: JS004
Study First Received: August 12, 2013
Last Updated: May 2, 2014
Health Authority: Sweden: Swedish National Council on Medical Ethics

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

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

ClinicalTrials.gov processed this record on July 28, 2014