Pharyngeal Dysfunction Clinical Trial
Official title:
Opioid-Induced Swallowing Dysfunction - The Impact of Bolus Volume: a Randomized, Double-Blind Study in Healthy Volunteers
The purpose of the study is to evaluate the impact of different bolus volumes and viscosity on remifentanil-induced swallowing dysfunction in healthy volunteers.Hence, whether swallowing tasks can be done safer during sedation by altering bolus volumes and viscosities will be revealed. Furthermore, the study will clarify underlying mechanisms (central vs. peripheral effects) of remifentanil-induced swallowing dysfunction. If methylnaltrexone reverses the remifentanil-induced effects on swallowing, this would suggest a dominant peripherally mediated mechanism.
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 different bolus volumes on remifentanil-induced
swallowing dysfunction in healthy volunteers. The study will clarify underlying mechanisms
(central vs. peripheral effects) of remifentanil-induced swallowing dysfunction. Furthermore,
whether swallowing tasks can be done safer during sedation by altering bolus volumes will be
revealed. In addition to bolus volume, different bolus viscosities will be tested. It is
shown that higher bolus viscosity diminishes misdirected swallows in dysphagic patients and
higher bolus viscosity may possibly counteracts the swallowing dysfunction induced by
remifentanil. Moreover, if MNTX reverses the remifentanil-induced effects on swallowing, then
this would suggest a dominant peripherally mediated mechanism. Our aim is also to evaluate
impact of remifentanil exposure on esophageal motility and impact of methylnaltrexone alone
on swallowing function.
20 healthy volunteers will be studied on two different occasions approximately one week
apart. In a randomized order volunteers will receive intravenous infusion of remifentanil and
an intravenous injection of MNTX on one occasion, and placebo (normal saline) infusion and an
intravenous injection of MNTX 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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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01012960 -
Opioids and Esophageal Function
|
Phase 4 | |
| Completed |
NCT01924234 -
Opioid Effects on Swallowing Comparing Younger and Elderly Volunteers
|
Phase 4 |