Recovery of muscle function after deep neuromuscular block by means of diaphragm ultrasonography and adductor of pollicis acceleromyography with comparison of neostigmine vs. sugammadex as reversal drugs: study protocol for a randomized controlled trial

Abstract

BackgroundThe extensive use of neuromuscular blocking agents (NMBAs) during surgical procedures still leads to potential residual paralyzing effects in the postoperative period. Indeed, neuromuscular monitoring in an intra-operative setting is strongly advocated. Acetylcholinesterase inhibitors can reverse muscle block, but their short half-life may lead to residual curarization in the ward, especially when intermediate or long-acting NMBAs have been administered. Sugammadex is the first selective reversal drug for steroidal NMBAs; it has been shown to give full and rapid recovery of muscle strength, thus minimizing the occurrence of residual curarization. Acceleromyography of the adductor pollicis is the gold standard for detecting residual curarization, but it cannot be carried out on conscious patients. Ultrasonography of diaphragm thickness may reveal residual effects of NMBAs in conscious patients.Methods/designThis prospective, double-blind, single-center randomized controlled study will enroll patients (of American Society of Anesthesiologists physical status I–II, aged 18–80 years) who will be scheduled to undergo deep neuromuscular block with rocuronium for ear, nose, or throat surgery. The study’s primary objective will be to compare the effects of neostigmine and sugammadex on postoperative residual curarization using two different tools: diaphragm ultrasonography and acceleromyography of the adductor pollicis. Patients will be extubated when the train-of-four ratio is > 0.9. Diaphragm ultrasonography will be used to evaluate the thickening fraction, which is the difference between the end expiratory thickness and the end inspiratory thickness, normalized to the end expiratory thickness. Ultrasonography will be performed before the initiation of general anesthesia, before extubation, and 10 and 30 min after discharging patients from the operating room. The secondary objective will be to compare the incidence of postoperative complications due to residual neuromuscular block between patients who receive neostigmine and those who receive sugammadex.DiscussionPostoperative residual curarization is a topic of paramount importance, because its occurrence can cause complications and increase the length of stay in hospital and the related costs. Diaphragm ultrasound assessment may become a bedside integrative tool in the neuromuscular monitoring field to detect concealed residual curarization in surgical patients who have received paralyzing agents.Trial registrationEudraCT, 2013-004787-62. Registered on 18 June 2014, as “Evaluation of muscle function recovery after deep neuromuscular blockade by acceleromyography of the adductor pollicis or diaphragmatic echography: comparison between sugammadex and neostigmine.”ClinicalTrials.gov, NCT02698969. Registered on 15 February 2016, as “Recovery of Muscle Function After Deep Neuromuscular Block by Means of Diaphragm Ultrasonography and Adductor Pollicis Acceleromyography: Comparison of Neostigmine vs. Sugammadex as Reversal Drugs.”Electronic supplementary materialT...

Application of ultrasound for muscle assessment in sarcopenia: 2020 SARCUS update

“…Diaphragm was evaluated at the mid-axillary line on the right side, at the level of either the 8th or the 9th intercostal space depending upon the clearest image, in a 30° head up supine position, the probe held perpendicular to the diaphragm, for muscle thickness [75]; at the midaxillary line in the apposition zone between the lung and liver on the right and between the lung and spleen on the left, in the intercostal spaces between the ninth, tenth, and eleventh ribs, 0.5-2 cm above the costophrenic sinus, for muscle thickness [76].…”

Diaphragm ultrasound to evaluate the antagonistic effect of sugammadex on rocuronium after liver surgery in patients with different liver Child-Pugh grades: study protocol for a prospective, double-blind, non-randomised controlled trial

“…Previous study has revealed that the reproducibility and repeatability of diaphragm ultrasonography are moderate. 20 As a new specific antagonist of aminosteroidal muscle relaxants, SUG is favoured by anaesthesiologists since it can effectively antagonise muscle relaxants at different depths. SUG has a wide range of applications, but its efficacy in special patients needs to be further explored, such as patients with severe liver insufficiency.…”

Getting to know a familiar face: Current and emerging focused ultrasound applications for the perioperative setting

“…Diminished diaphragm contractility measured as a thickening fraction on M‐mode ultrasound at the zone of apposition correlate with extubation failure in adults . Finally, ultrasound‐based measurement of diaphragm thickening fraction is under investigation as a means to assess for postoperative residual neuromuscular blockade after administration of neuromuscular blockade reversal agents …”