DeglutitionPhase 4DexSwallowNCT03390972
Dexmedetomidine and Swallowing Function
A Phase 4 study testing Dexmedetomidine in people with Deglutition, run by Region Örebro County.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Deglutition
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 22 Jan 2018to 11 Apr 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ≥ 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effects of Dexmedetomidine on Swallowing Function: a Randomized, Double-Blind Study in Healthy Volunteers
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.
Read the detailed description
Monitored anesthesia care (MAC) is commonly applied in modern perioperative care and means that minor surgical procedures are accomplished in awake patients using local anesthesia and light sedation. MAC has many advantages compared to general anesthesia; the recovery time after anesthesia is shorter and risk for postoperative nausea is lower to mention some. However, the patient is spontaneously breathing and the airway is not protected by an endotracheal tube which potentially increases risk of pulmonary aspiration. Pulmonary aspiration, that is inhalation of stomach and/or pharyngeal contents into the lungs, is a severe anesthesia-related complication and can in worst case lead to pneumonia and even death. Intact swallowing function is crucial in avoiding aspiration and how sedatives and analgesic agents used during MAC influence swallowing function is not fully understood.
Pharyngeal function during bolus swallowing is measured by combined high resolution impedance manometry (HRIM). The HRIM catheter is inserted through the nose in such a way that sensors straddle the entire pharynx and esophagus with the distal catheter tip in the stomach. Dynamic pressure changes and flow can be detected during swallowing and data registered by HRIM are analysed using purpose-designed software, AIM analysis (automated impedance manometry analysis). AIM analysis derives pressure flow variables which describe different physiological events like bolus timing and bolus distension in the pharynx and the esophagus during swallowing. A Swallow Risk Index value, quantifying risk of deglutitive aspiration, can also be defined.
The aim of the study is to evaluate impact of dexmedetomidine on swallowing function in healthy volunteers.Dexmedetomidine is a selective alfa-agonist frequently used during MAC. Furthermore, two different concentrations of dexmedetomidine will be studied to find out whether any posible impact of dexmedetomidine on swallowing function is dose-dependent. Moreover, subjective swallowing difficulties will be assessed.
20 healthy volunteers will be studied on two different occasions approximately one week apart. In a randomized order volunteers will receive intravenous infusion of dexmedetomidine in two subsequent concentrations and placebo (normal saline) infusion in corresponding doses on the other occasion. Blood samples are obtained for plasma concentration determination of the study drug and sedation levels are assessed during study drug exposure.
- Conditions
- Deglutition
- Being tested
- Placebo, Dexmedetomidine
- Keywords
- Dexmedetomidine, Swallowing function, Anesthetic sedation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Also called Sodium Chloride 0.9%
Placebo (NaCl 0.9%) TCI infusion
DexmedetomidineDrug
Also called Dexdor
Dexmedetomidine TCI 0.6 ng/ml and 1.2 ng/ml
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine | Experimental | Volunteers 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. Receives: Drug: Dexmedetomidine |
| Placebo | Placebo comparator | Volunteers are given an intravenous infusion with saline 0,9% with target controlled infusion pump in corresponding doses as in the dexmedetomidine arm. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 60 minutes
Hypopharyngeal Intrabolus Pressure, dex vs baseline
Measure of pharyngeal outflow resistance, mmHg
Measured: 60 min
Mean Distension Contraction Latency, dex vs baseline
Measure of flow timing, sec
Measured: 60 min
Hypopharyngeal Bolus Presence Time, dex vs baseline
Measure of bolus arrival/oral bolus control, sec
Measured: 60 min
Velopharyngeal to Tongue Base Pressure Integral, dex vs baseline
Measure of lumen occlusive pressure, mmHgxsxcm
Measured: 60 min
Hypopharyngeal Contractile Integral, dex vs baseline
Measure of lumen occlusive pressure, mmHgxsxcm
Measured: 60 min
Mean Pharyngeal Peak Pressure, dex vs baseline
Measure of lumen occlusive pressure, mmHg
Measured: 60 min
Mean UES Basal Pressure, dex vs baseline
Measure of UES (upper esophageal sphincter) basal tone, mmHg
Measured: 60 min
UES Open Time, dex vs baseline
Measure of UES opening, sec
Measured: 60 min
UES Maximum Admittance
Measure of UES opening, ms
Measured: 60 min
UES Integrated Relaxation Pressure
Measure of UES relaxation, mmHg
Measured: 60 min
Secondary outcomes (4)
Pharyngeal Pressure Flow variables, dex 0.6 ng/ml vs 1.2 ng/ml
Difference in pressure flow variables during swallowing between dexmedetomidine target concentration of 0.6 ng/ml and 1.2 ng/ml compared to placebo.
Measured: 60 minutes
Esophageal pressure flow variables, dex vs baseline
Difference in pressure flow variables during swallowing between dexmedetomidine exposure and baseline compared to placebo.
Measured: 60 min
Esophageal pressure flow variables, dex 0.6 ng/ml vs 1.2 ng/ml
Difference in esophageal pressure flow variables during swallowing between dexmedetomidine target concentration of 0.6 ng/ml and 1.2 ng/ml compared to placebo.
Measured: 60 min
Subjective swallowing difficulties
Difference in subjective swallowing difficulties between dexmedetomidine exposure and baseline compared to placebo.
Measured: 60 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start22 Jan 2018 (estimated)
- Primary completion11 Apr 2018 (estimated)
- Study completion11 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeglutitionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Johanan Savilampi, Phd, Principal investigator, Department of Anaesthesiology and Intensive Care, Örebro University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03390972
- Sponsor's protocol ID
- JS007
- Acronym
- DexSwallow
- Status last verified
- Dec 2017
- First submitted
- 14 Dec 2017
- Last updated
- 5 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Dexmedetomidine on Swallowing Function: a Randomized, Double-Blind Study in Healthy Volunteers
- ClinicalTrials.gov ID
- NCT03390972
- Acronym / sponsor ID
- DexSwallow / JS007
- Conditions
- Deglutition
- Keywords
- Dexmedetomidine, Swallowing function, Anesthetic sedation
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Study start
- 22 Jan 2018 (estimated)
- Primary completion
- 11 Apr 2018 (estimated)
- Study completion
- 11 Apr 2018 (estimated)
- First posted
- 5 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Monitored anesthesia care (MAC) is commonly applied in modern perioperative care and means that minor surgical procedures are accomplished in awake patients using local anesthesia and light sedation. MAC has many advantages compared to general anesthesia; the recovery time after anesthesia is shorter and risk for postoperative nausea is lower to mention some. However, the patient is spontaneously breathing and the airway is not protected by an endotracheal tube which potentially increases risk of pulmonary aspiration. Pulmonary aspiration, that is inhalation of stomach and/or pharyngeal contents into the lungs, is a severe anesthesia-related complication and can in worst case lead to pneumonia and even death. Intact swallowing function is crucial in avoiding aspiration and how sedatives and analgesic agents used during MAC influence swallowing function is not fully understood.
Pharyngeal function during bolus swallowing is measured by combined high resolution impedance manometry (HRIM). The HRIM catheter is inserted through the nose in such a way that sensors straddle the entire pharynx and esophagus with the distal catheter tip in the stomach. Dynamic pressure changes and flow can be detected during swallowing and data registered by HRIM are analysed using purpose-designed software, AIM analysis (automated impedance manometry analysis). AIM analysis derives pressure flow variables which describe different physiological events like bolus timing and bolus distension in the pharynx and the esophagus during swallowing. A Swallow Risk Index value, quantifying risk of deglutitive aspiration, can also be defined.
The aim of the study is to evaluate impact of dexmedetomidine on swallowing function in healthy volunteers.Dexmedetomidine is a selective alfa-agonist frequently used during MAC. Furthermore, two different concentrations of dexmedetomidine will be studied to find out whether any posible impact of dexmedetomidine on swallowing function is dose-dependent. Moreover, subjective swallowing difficulties will be assessed.
20 healthy volunteers will be studied on two different occasions approximately one week apart. In a randomized order volunteers will receive intravenous infusion of dexmedetomidine in two subsequent concentrations and placebo (normal saline) infusion in corresponding doses on the other occasion. Blood samples are obtained for plasma concentration determination of the study drug and sedation levels are assessed during study drug exposure.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine | Experimental | Drug: DexmedetomidineVolunteers 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 comparator | Drug: PlaceboVolunteers are given an intravenous infusion with saline 0,9% with target controlled infusion pump in corresponding doses as in the dexmedetomidine arm. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ≥ 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlaceboAlso: Sodium Chloride 0.9%Placebo (NaCl 0.9%) TCI infusion | Drug | Placebo |
| DexmedetomidineAlso: DexdorDexmedetomidine TCI 0.6 ng/ml and 1.2 ng/ml | Drug | Dexmedetomidine |
Primary outcome
Swallow Risk Index, dex vs baseline
Time frame: 60 minutes
Global measure of swallowing dysfunction related to aspiration risk, during swallowing between dexmedetomidine exposure and baseline compared to placebo.
Hypopharyngeal Intrabolus Pressure, dex vs baseline
Time frame: 60 min
Measure of pharyngeal outflow resistance, mmHg
Mean Distension Contraction Latency, dex vs baseline
Time frame: 60 min
Measure of flow timing, sec
Hypopharyngeal Bolus Presence Time, dex vs baseline
Time frame: 60 min
Measure of bolus arrival/oral bolus control, sec
Velopharyngeal to Tongue Base Pressure Integral, dex vs baseline
Time frame: 60 min
Measure of lumen occlusive pressure, mmHgxsxcm
Hypopharyngeal Contractile Integral, dex vs baseline
Time frame: 60 min
Measure of lumen occlusive pressure, mmHgxsxcm
Mean Pharyngeal Peak Pressure, dex vs baseline
Time frame: 60 min
Measure of lumen occlusive pressure, mmHg
Mean UES Basal Pressure, dex vs baseline
Time frame: 60 min
Measure of UES (upper esophageal sphincter) basal tone, mmHg
UES Open Time, dex vs baseline
Time frame: 60 min
Measure of UES opening, sec
UES Maximum Admittance
Time frame: 60 min
Measure of UES opening, ms
UES Integrated Relaxation Pressure
Time frame: 60 min
Measure of UES relaxation, mmHg
4 secondary outcomes
Pharyngeal Pressure Flow variables, dex 0.6 ng/ml vs 1.2 ng/ml
Time frame: 60 minutes
Esophageal pressure flow variables, dex vs baseline
Time frame: 60 min
Esophageal pressure flow variables, dex 0.6 ng/ml vs 1.2 ng/ml
Time frame: 60 min
Subjective swallowing difficulties
Time frame: 60 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Johanan Savilampi, Phd principal investigator
Department of Anaesthesiology and Intensive Care, Örebro University Hospital
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine in people with Deglutition, run by Region Örebro County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Johanna Savilampi, Phd (+46 019 6020266, johanna.savilampi@regionorebrolan.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Swallow Risk Index, dex vs baseline (time frame: 60 minutes). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2018.