Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers
1 other identifier
interventional
18
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_4
Started Aug 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 12, 2013
CompletedFirst Posted
Study publicly available on registry
August 16, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedDecember 3, 2014
December 1, 2014
1.3 years
August 12, 2013
December 2, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pressure-Flow Variables measured by combined manometry and impedance system ( ManoScan 360) during pharyngeal swallowing
up to 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection)
Secondary Outcomes (1)
Subjective swallowing difficulties measured by 4-point scale
Variables are measured before (baseline) and 15 min and 30 minutes after opioidadministration (after start of remifentanil infusion or morphine injection)
Study Arms (2)
morphine
ACTIVE COMPARATORVolunteers are given morphine injection
remifentanil
ACTIVE COMPARATORVolunteers are given remifentanil infusion
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Örebro University Hospital
Örebro, 70185, Sweden
Related Publications (1)
Savilampi J, Omari T, Magnuson A, Ahlstrand R. Effects of remifentanil on pharyngeal swallowing: A double blind randomised cross-over study in healthy volunteers. Eur J Anaesthesiol. 2016 Sep;33(9):622-30. doi: 10.1097/EJA.0000000000000461.
PMID: 27191923DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johanna Savilampi, M.D
Department of Anesthesiology and Intensive Care, Örebro University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- BASIC SCIENCE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D.
Study Record Dates
First Submitted
August 12, 2013
First Posted
August 16, 2013
Study Start
August 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
December 3, 2014
Record last verified: 2014-12