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Online ISSN 1827-1596
Guillaume BESCH 1, 2, Angeline CHOPARD-GUILLEMIN 1, Elisabeth MONNET 3, Arnaud CAUSERET 1, Amelie JURINE 1, Gerald BAUDRY 1, Benjamin LASRY 1, Laurent TAVERNIER 4, Emmanuel SAMAIN 1, 2, Sebastien PILI-FLOURY 1, 2
1 Department of Anesthesiology and Intensive Care Medicine, University Hospital of Besancon, University of Franche-Comte, Besancon, France; 2 EA 3920, INSERM SFR 133, Besancon, France; 3 Clinical Investigation Center, University Hospital of Besancon, and SFR-FED 4234, University of Franche-Comte, Besancon, France; 4 Department of ENT Surgery, University Hospital of Besancon, and EA 481 and SFR-FED 4234, University of Franche-Comte, Besancon, France
BACKGROUND: The ENDOTANIL trial aimed at comparing an association of target-controlled infusion (TCI) of remifentanil and propofol to TCI of propofol alone on the clinical conditions during pan endoscopy for assessment of the upper airway (pan endoscopy) performed under tubeless general anesthesia.
METHODS: This double-blind, single center, parallel, randomized, placebo-controlled trial was conducted in a French tertiary level of care, from June 2009 to February 2013. Patients scheduled for elective pan endoscopy were anesthetized using propofol TCI combined to either remifentanil TCI (effect-site concentration=1.5 ng.ml-1; Remifentanil group) or placebo (Control group). The main outcome measure was the percentage of clinically acceptable conditions for pan endoscopy, using a 5-criteria score (ease of laryngoscopy, position and movements of the vocal cords, cough and movements of the limbs to stimulation). The secondary outcomes were hemodynamic and respiratory safety.
RESULTS: 218 patients (mean (SD) age 60 (10) yrs) were included. Clinically acceptable conditions were observed in 68% and 64% of the patients included in Remifentanil and Control group, respectively (p=0.39). None of the 5 parameters of the pan endoscopy score was significantly different between the 2 groups. Hemodynamic alterations were significantly lower in the Remifentanil as compared to the Control group. Incidence of hypoxemia or need for rescue mechanical ventilation did not significantly differ between the 2 groups.
CONCLUSIONS: The adjunction of remifentanil to propofol TCI, at a dose that maintain spontaneous breathing, did not improve the conditions for pan endoscopy, but attenuates the hemodynamic response induced by upper airway stimulation.