Deglutition Clinical Trial
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.
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.
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