Dexmedetomidine and Swallowing Function

Deglutition Clinical Trial

— DexSwallow  

Official title:

Effects of Dexmedetomidine on Swallowing Function: a Randomized, Double-Blind Study in Healthy Volunteers

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03390972
• Other study ID #: JS007
• Status: Not yet recruiting
• Phase: Phase 4
• First received: December 14, 2017
• Last updated: December 28, 2017
• Start date: January 22, 2018
• Est. completion date: April 11, 2018

Study information

• Verified date: December 2017
• Source: Region Örebro County
• Contact: Johanna Savilampi, Phd
• Phone: +46 019 6020266
• Email: johanna.savilampi[@]regionorebrolan.se
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 function is dose-dependent.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 20
• Est. completion date: April 11, 2018
• Est. primary completion date: April 11, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

1. = 18 - = 40 year old healthy volunteers from both sexes.

2. Have signed and dated Informed Consent.

3. Willing and able to comply with the protocol for the duration of the trial.

Exclusion Criteria:

1. Anamnesis of pharyngoesophageal dysfunction.

2. Known or history of gastrointestinal, severe cardiac, pulmonary or neurological disease

3. Ongoing medication that may affect upper gastrointestinal tract, larynx or lower airway.

4. Allergies to or history of reaction to remifentanil, fentanyl analogues or dexmedetomidine.

5. Known heart rhythm disorder.

6. Tendency to faint.

7. Pregnancy or breast feeding

8. BMI > 30

9. Smoking

10. 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.

Related Conditions & MeSH terms

• Deglutition

Intervention

Drug:
• Placebo
Placebo (NaCl 0.9%) TCI infusion
• Dexmedetomidine
Dexmedetomidine TCI 0.6 ng/ml and 1.2 ng/ml

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Region Örebro County

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Hypopharyngeal Intrabolus Pressure, dex vs baseline	Measure of pharyngeal outflow resistance, mmHg	60 min
Primary	Mean Distension Contraction Latency, dex vs baseline	Measure of flow timing, sec	60 min
Primary	Hypopharyngeal Bolus Presence Time, dex vs baseline	Measure of bolus arrival/oral bolus control, sec	60 min
Primary	Velopharyngeal to Tongue Base Pressure Integral, dex vs baseline	Measure of lumen occlusive pressure, mmHgxsxcm	60 min
Primary	Hypopharyngeal Contractile Integral, dex vs baseline	Measure of lumen occlusive pressure, mmHgxsxcm	60 min
Primary	Mean Pharyngeal Peak Pressure, dex vs baseline	Measure of lumen occlusive pressure, mmHg	60 min
Primary	Mean UES Basal Pressure, dex vs baseline	Measure of UES (upper esophageal sphincter) basal tone, mmHg	60 min
Primary	UES Open Time, dex vs baseline	Measure of UES opening, sec	60 min
Primary	UES Maximum Admittance	Measure of UES opening, ms	60 min
Primary	UES Integrated Relaxation Pressure	Measure of UES relaxation, mmHg	60 min
Secondary	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.	60 minutes
Secondary	Esophageal pressure flow variables, dex vs baseline	Difference in pressure flow variables during swallowing between dexmedetomidine exposure and baseline compared to placebo.	60 min
Secondary	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.	60 min
Secondary	Subjective swallowing difficulties	Difference in subjective swallowing difficulties between dexmedetomidine exposure and baseline compared to placebo.	60 minutes