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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.
Trials. 2018 Feb 21; 19(1):135.T

Abstract

BACKGROUND

The 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/DESIGN

This 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.

DISCUSSION

Postoperative 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 REGISTRATION

EudraCT, 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."

Authors+Show Affiliations

Department of Health Sciences, Section of Anesthesiology and Critical Care, University of Florence, Largo Brambilla 3, 50134, Florence, Italy. jacopocappellini@gmail.com.Department of Health Sciences, Section of Anesthesiology and Critical Care, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.Department of Health Sciences, Section of Anesthesiology and Critical Care, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.Department of Health Sciences, Section of Anesthesiology and Critical Care, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.Department of Health Sciences, Section of Anesthesiology and Critical Care, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.Department of Health Sciences, Section of Anesthesiology and Critical Care, University of Florence, Largo Brambilla 3, 50134, Florence, Italy.

Pub Type(s)

Clinical Trial Protocol
Journal Article

Language

eng

PubMed ID

29467022

Citation

Cappellini, Iacopo, et al. "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." Trials, vol. 19, no. 1, 2018, p. 135.
Cappellini I, Picciafuochi F, Ostento D, et al. 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. Trials. 2018;19(1):135.
Cappellini, I., Picciafuochi, F., Ostento, D., Danti, G., De Gaudio, A. R., & Adembri, C. (2018). 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. Trials, 19(1), 135. https://doi.org/10.1186/s13063-018-2525-7
Cappellini I, et al. 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. Trials. 2018 Feb 21;19(1):135. PubMed PMID: 29467022.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Cappellini,Iacopo, AU - Picciafuochi,Fabio, AU - Ostento,Daniele, AU - Danti,Ginevra, AU - De Gaudio,Angelo Raffaele, AU - Adembri,Chiara, Y1 - 2018/02/21/ PY - 2017/03/27/received PY - 2018/02/05/accepted PY - 2018/2/23/entrez PY - 2018/2/23/pubmed PY - 2019/3/15/medline KW - Curarization KW - Diaphragm ultrasonography KW - Neuromuscular monitoring KW - Postoperative residual KW - Sugammadex SP - 135 EP - 135 JF - Trials JO - Trials VL - 19 IS - 1 N2 - BACKGROUND: The 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/DESIGN: This 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. DISCUSSION: Postoperative 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 REGISTRATION: EudraCT, 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." SN - 1745-6215 UR - https://www.unboundmedicine.com/medline/citation/29467022/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_ L2 - https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-018-2525-7 DB - PRIME DP - Unbound Medicine ER -