Dexmedetomidine and Swallowing Function
DexSwallow
Effects of Dexmedetomidine on Swallowing Function: a Randomized, Double-Blind Study in Healthy Volunteers
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
The purpose of the study is to evaluate the impact of dexmedetomidine on swallowing function in healthy volunteers using combined pressure and impedance recordings. Furthermore, two different concentrations of dexmedetomidine will be studied to find out whether any posible impact of dexmedetomidine on swallowing function is dose-dependent.
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 Jan 2018
Shorter than P25 for phase_4
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
First Submitted
Initial submission to the registry
December 14, 2017
CompletedFirst Posted
Study publicly available on registry
January 5, 2018
CompletedStudy Start
First participant enrolled
January 22, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 11, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
April 11, 2018
CompletedJanuary 5, 2018
December 1, 2017
3 months
December 14, 2017
December 28, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (11)
Swallow Risk Index, dex vs baseline
Global measure of swallowing dysfunction related to aspiration risk, during swallowing between dexmedetomidine exposure and baseline compared to placebo.
60 minutes
Hypopharyngeal Intrabolus Pressure, dex vs baseline
Measure of pharyngeal outflow resistance, mmHg
60 min
Mean Distension Contraction Latency, dex vs baseline
Measure of flow timing, sec
60 min
Hypopharyngeal Bolus Presence Time, dex vs baseline
Measure of bolus arrival/oral bolus control, sec
60 min
Velopharyngeal to Tongue Base Pressure Integral, dex vs baseline
Measure of lumen occlusive pressure, mmHgxsxcm
60 min
Hypopharyngeal Contractile Integral, dex vs baseline
Measure of lumen occlusive pressure, mmHgxsxcm
60 min
Mean Pharyngeal Peak Pressure, dex vs baseline
Measure of lumen occlusive pressure, mmHg
60 min
Mean UES Basal Pressure, dex vs baseline
Measure of UES (upper esophageal sphincter) basal tone, mmHg
60 min
UES Open Time, dex vs baseline
Measure of UES opening, sec
60 min
UES Maximum Admittance
Measure of UES opening, ms
60 min
UES Integrated Relaxation Pressure
Measure of UES relaxation, mmHg
60 min
Secondary Outcomes (4)
Pharyngeal Pressure Flow variables, dex 0.6 ng/ml vs 1.2 ng/ml
60 minutes
Esophageal pressure flow variables, dex vs baseline
60 min
Esophageal pressure flow variables, dex 0.6 ng/ml vs 1.2 ng/ml
60 min
Subjective swallowing difficulties
60 minutes
Study Arms (2)
Dexmedetomidine
EXPERIMENTALVolunteers are given an intravenous infusion with dexmedetomidine, with an effect-site target concentration of 0.6 ng/ml via a target-controlled infusion (TCI) pump. After a series of swallowing tests the effect-site target concentration is raised to 1.2 ng/ml and the swallowing series is repeated.
Placebo
PLACEBO COMPARATORVolunteers are given an intravenous infusion with saline 0,9% with target controlled infusion pump in corresponding doses as in the dexmedetomidine arm.
Interventions
Eligibility Criteria
You may qualify if:
- ≥ 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.
You may not qualify if:
- Anamnesis of pharyngoesophageal dysfunction.
- Known or history of gastrointestinal, severe cardiac, pulmonary or neurological disease
- Ongoing medication that may affect upper gastrointestinal tract, larynx or lower airway.
- Allergies to or history of reaction to remifentanil, fentanyl analogues or dexmedetomidine.
- Known heart rhythm disorder.
- Tendency to faint.
- Pregnancy or breast feeding
- BMI \> 30
- Smoking
- Participation in a medicinal clinical trial during the last year where an opioid has been used or have during the last 30 days participated in any other medicinal clinical trial or in a trial where follow-up is not completed.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Johanan Savilampi, Phd
Department of Anaesthesiology and Intensive Care, Örebro University Hospital
Central Study Contacts
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
- SPONSOR
Study Record Dates
First Submitted
December 14, 2017
First Posted
January 5, 2018
Study Start
January 22, 2018
Primary Completion
April 11, 2018
Study Completion
April 11, 2018
Last Updated
January 5, 2018
Record last verified: 2017-12
Data Sharing
- IPD Sharing
- Will not share