RESUMEN
BACKGROUND: Tracheal intubation with neuromuscular blocking agents is associated with a low incidence of minor vocal cord sequelae (8%). The aim of this noninferiority trial was to demonstrate that the frequency of vocal cord sequelae after fiberoptic intubation with a flexible silicone tube without neuromuscular blocking agents was less than 25% (maximum tolerable inferiority). METHODS: Two-hundred seventy patients were prospectively randomized to two groups. All intubations were performed by anesthesiologists with extensive experience in fiberoptic and conventional techniques. Fiberoptic nasotracheal intubation consisted of a bolus dose of 2 microg/kg fentanyl; 0.25 ml cocaine instillation, 10%, into nasal canals; cricothyroid injection of 2 ml lidocaine, 1%; bronchoscopy; administration of 0.3 mg/kg etomidate; and advancing a flexible silicone tube after loss of consciousness. Orotracheal intubation was performed with a polyvinyl chloride tube after induction with 2 microg/kg fentanyl, 2 mg/kg propofol, and 0.6 mg/kg rocuronium. Patients were examined by laryngoscopy before surgery, 24 h after surgery, and daily until complete restitution. Postoperative hoarseness was assessed by a standardized interview. RESULTS: The incidence of vocal cord sequelae was 11 out of 130 (8.5%) in the fiberoptic group versus 12 out of 129 (9.3%) in the control group (chi-square = 0.057, df = 1, P = 0.81; upper limit of the one-sided 95% confidence interval for the difference: +5.1%). There were no persistent injuries. The incidence of postoperative hoarseness was 4% in both groups. CONCLUSIONS: Because fiberoptic intubation without neuromuscular blocking agents is safe regarding vocal cord sequelae, routine use is justified for anesthesiologists experienced in this technique.