Airway Complication of Anesthesia Clinical Trial
Official title:
Awake Fiber Optic Intubation (AFOI) in Patients With Stenosis of the Upper Airway: Utility of the Laryngeal Nervous Block
Oncologic laryngeal surgery is a challenge for anesthesiologists and awake fiberoptic intubation (AFOI) is mandatory to manage difficult airways and prevent the Can't Intubate Can't Oxigenate (CICO). Laryngospasm and oversedation are dangerous complication often life-threatening in this kind of patient. Superior laryngeal nerve block (SLNB) could be an alternative technique useful to reduce risks and to improve patient comfort. Aim of this study is to assess the procedural comfort of the SLNB during AFOI, in a population of patients suffering from severe airways obstruction undergoing pharyngeal-laryngeal surgery. 40 patients will be randomized in two groups(20 for each group) and will be treated with continuous infusion of remifentanil, topic anesthesia of the base of the tongue and intercricoid block. In group A will be associated the SLNB; placebo will be administered in group B.
Patients will be randomized in two groups: group A: treated with continuous infusion of
remifentanil, topic anesthesia of the base of the tongue, intercricoid block and SLNB; group
B: treated with continuous infusion of remifentanil, topic anesthesia of the base of the
tongue and intercricoid block. After the first measurement of vital parameters (T0), patients
will received a continuous intravenous infusion of remifentanil at a rate ranged between 0.05
and 0.15 mcg/kg/min, reached by titration of a conscious sedation plane corresponding to the
0/-1 stage of the RASS scale. In all patients of both groups topical anesthesia of the
oropharynx mucosa will be performed through 10 puffs of 10% lidocaine spray at the back of
the tongue and at the base of the palatopharyngeal and palatoglossal arch. In Group A SLNB
will be performed by administering 4 ml of 1.5% lidocaine below the thyroid membrane, which
is palpated in addition to the intercricoid block by translaringeal puncture and 4 ml of
lidocaine 1,5%. In group B intercricoid block will be performed by translaringeal puncture
and 4 ml of 1.5% lidocaine. Group B will receive placebo instead of the regional block. After
regional anesthesia, the patient will be placed on the operating table with the head in a
neutral position. The vital parameters and the level of sedation reached (T1) will be
registered. If SpO2 will be less than 96%, the patient will be pre-oxygenated with FiO2 100%.
AFOI procedure will be performed using a 4 mm Olympus LF-2 bronchoscope and spiral tracheal
tubes (internal diameter of between 5-6 mm) will be used. Discomfort during AFOI will be
evaluated through the Fiber Optic Intubation Comfort Score. During AFOI procedure,
unstructured airway maneuvers (neck's hyperextension, jaw subluxation, and pulling the tongue
manually) will be evaluated. Hypoxemia, aspiration of secretions and time to perform
intubation will be reported.
After intubation, a new evaluation of the vital parameters will be performed (T2) and
patients will undergo to a total intravenous general anesthesia in accordance with the
current international protocols. The primary endpoint will be to evaluate if SLNB is able to
reduce the degree of discomfort of the AFOI procedure measured with the relative risk of
Fiber Optic Intubation Comfort Score > 1. Secondary endpoint will be incidence of hypoxemia,
time required to intubate, intraprocedural hemodynamic stability, airway obstruction score,
need to aspirate secretions during AFOI, Tracheal Tube Tolerance Score.
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