Eugenio Garofalo1, Andrea Bruni1, Giuseppe Scalzi1, Lucia Stella Curto2, Serena Rovida3, Vincenzo Brescia1, Rita Gervasi2, Paolo Navalesi4, Nadia Innaro2, Federico Longhini5. 1. Anesthesia and Intensive Care, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro, Italy. 2. Endocrine Surgery Unit, "Mater Domini" University Hospital, Catanzaro, Italy. 3. Department of Emergency Medicine, Royal London Hospital, Barts Health NHS Trust, United Kingdom. 4. Anesthesia and Intensive Care, Padua Hospital, Department of Medicine - DIMED, University of Padua, Italy. 5. Anesthesia and Intensive Care, Department of Medical and Surgical Sciences, "Magna Graecia" University, Catanzaro, Italy. Electronic address: longhini.federico@gmail.com.
Abstract
BACKGROUND:Intraoperative Neurophysiological Monitoring (IONM) reduces the incidence of Recurrent Laryngeal Nerve (RLN) injuries during thyroid surgery. To preserve nerve function, long acting neuromuscular blocking agents (NMBA) should be avoided. However, NMBA are necessary for laryngoscopy and endotracheal intubation. We designed this double-blinded, randomized, placebo-controlled trial to assess if a low-dose of rocuronium given at intubation would affect the IONM data recorded before the thyroid dissection. METHODS:Hundred patients undergoing elective thyroid surgery were randomized to receive either 0.3 mg kg-1 of low dose rocuronium (intervention) or no-NMBA (control). Intubation was performed with video-laryngoscopy. IONM was placed on RLN and nerve stimulation was performed before and after thyroid dissection. The presence of a valid amplitude prior to dissection was defined when the IONM signal was >100 μV. Occurrence of difficult laryngoscopy was reported together with intubation details including time, difficulty and failure. The lowest peripheral saturation (SpO2) and the number of desaturation episodes during the intubation were also registered. RESULTS: No patients showed impaired IONM signal before dissection in both groups. Cormack-Lehane grade was higher in the intervention group (11;2) compared to control one (11;1; P = 0.046). No-NMBA patients had increased number of difficult laryngoscopies (21% versus 6%, P = 0.041) and intubations (34% versus 8%; P = 0.003) as well as a longer time to intubation (78 [55; 175] versus 55 [31; 110] sec; P = 0.006). Lower values of peripheral SpO2 during intubation attempt were registered in the no NMBA group (99 [97; 100] versus 99 [99; 100] %; P = 0.020). However, the number of intubation failure was similar between groups (p=0.495). CONCLUSIONS: Low-dose of rocuronium does not compromise pre-dissection IONM signal and improves intubation condition when compared to a relaxant free strategy.
RCT Entities:
BACKGROUND: Intraoperative Neurophysiological Monitoring (IONM) reduces the incidence of Recurrent Laryngeal Nerve (RLN) injuries during thyroid surgery. To preserve nerve function, long acting neuromuscular blocking agents (NMBA) should be avoided. However, NMBA are necessary for laryngoscopy and endotracheal intubation. We designed this double-blinded, randomized, placebo-controlled trial to assess if a low-dose of rocuronium given at intubation would affect the IONM data recorded before the thyroid dissection. METHODS: Hundred patients undergoing elective thyroid surgery were randomized to receive either 0.3 mg kg-1 of low dose rocuronium (intervention) or no-NMBA (control). Intubation was performed with video-laryngoscopy. IONM was placed on RLN and nerve stimulation was performed before and after thyroid dissection. The presence of a valid amplitude prior to dissection was defined when the IONM signal was >100 μV. Occurrence of difficult laryngoscopy was reported together with intubation details including time, difficulty and failure. The lowest peripheral saturation (SpO2) and the number of desaturation episodes during the intubation were also registered. RESULTS: No patients showed impaired IONM signal before dissection in both groups. Cormack-Lehane grade was higher in the intervention group (11;2) compared to control one (11;1; P = 0.046). No-NMBA patients had increased number of difficult laryngoscopies (21% versus 6%, P = 0.041) and intubations (34% versus 8%; P = 0.003) as well as a longer time to intubation (78 [55; 175] versus 55 [31; 110] sec; P = 0.006). Lower values of peripheral SpO2 during intubation attempt were registered in the no NMBA group (99 [97; 100] versus 99 [99; 100] %; P = 0.020). However, the number of intubation failure was similar between groups (p=0.495). CONCLUSIONS: Low-dose of rocuronium does not compromise pre-dissection IONM signal and improves intubation condition when compared to a relaxant free strategy.