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Effects of neuromuscular block reversal with sugammadex versus neostigmine on postoperative respiratory outcomes after major abdominal surgery: a randomized-controlled trial

  • Enrique AldayEmail author
  • Manolo Muñoz
  • Antonio Planas
  • Esperanza Mata
  • Carlos Alvarez
Reports of Original Investigations

Abstract

Purpose

Postoperative pulmonary complications may be better reduced by reversal of neuromuscular block with sugammadex than by reversal with neostigmine because the incidence of residual block after sugammadex application is lower and diaphragm function is less impaired than after neostigmine administration. The aim of the study was to compare the effect of reversal of neuromuscular block with sugammadex or neostigmine on lung function after major abdominal surgery.

Methods

One hundred and thirty adults scheduled for major abdominal surgery under combined general and epidural anesthesia were randomly allocated to receive 40 µg of neostigmine or 4 mg·kg−1 of sugammadex to reverse neuromuscular block. Two blinded researchers performed spirometry and lung ultrasound before the surgery, as well as 1 hr and 24 hr postoperatively. Differences in mean changes from baseline were analyzed with repeated measures analysis of variance. Forced vital capacity (FVC) loss one hour after surgery was the main outcome. Secondary outcomes were differences in rate and size of atelectasis one hour and 24 hr after surgery.

Results

One hundred twenty-six patients were included in the main analysis. In the neostigmine group (n = 64), mean (95% confidence interval [95% CI]) reduction in FVC after one hour was 0.5 (0.4 to 0.6) L. In the sugammadex group (n = 62), the mean (95% CI) reduction in FVC during the first hour was 0.5 (95% CI, 0.3 to 0.6) L. Thirty-nine percent of patients in the neostigmine group and 29% in the sugammadex group had visible atelectasis. Median [interquartile range (IQR)] atelectasis area was 9.7 [4.7–13.1] cm2 and 6.8 [3.6–12.5] cm2, respectively.

Conclusion

We found no differences in pulmonary function in patients reversed with sugammadex or neostigmine in a high-risk population.

Trial registration

EudraCT 2014-005156-26; registered 27 May, 2015.

Effets du renversement du bloc neuromusculaire à l’aide de sugammadex vs de la néostigmine sur l’évolution respiratoire postopératoire après une chirurgie abdominale majeure: une étude randomisée contrôlée

Résumé

Objectif

Les complications pulmonaires postopératoires pourraient être mieux contrôlées en neutralisant le bloc neuromusculaire avec du sugammadex plutôt qu’avec de la néostigmine; en effet, l’incidence de bloc résiduel après l’administration de sugammadex est plus faible et la fonction du diaphragme moins affectée qu’après l’administration de néostigmine. L’objectif de cette étude était de comparer l’effet d’une neutralisation du bloc neuromusculaire réalisée à l’aide de sugammadex vs de la néostigmine sur la fonction pulmonaire après une chirurgie abdominale majeure.

Méthode

Cent trente adultes devant subir une chirurgie abdominale majeure sous anesthésie générale et péridurale combinée ont été randomisés à recevoir 40 µg de néostigmine ou 4 mg·kg1 de sugammadex afin de neutraliser le bloc neuromusculaire. Deux chercheurs en aveugle ont réalisé une spirométrie et une échographie pulmonaire avant la chirurgie, ainsi que 1 h et 24 h après l’opération. Les différences de changements moyens par rapport aux mesures de départ ont été analysées à l’aide de mesures répétées d’analyse de la variance. La perte de capacité vitale forcée (CVF) une heure après la chirurgie était notre critère d’évaluation principal. Les critères secondaires comprenaient les différences des taux et de taille de l’atélectasie une heure et 24 h après la chirurgie.

Résultats

Cent vingt-six patients ont été inclus dans l’analyse principale. Dans le groupe néostigmine (n = 64), la réduction moyenne (intervalle de confiance 95 % [IC 95 %]) de CVF après une heure était de 0,5 (0,4 à 0,6) L. Dans le groupe sugammadex (n = 62), la réduction moyenne (IC 95 %) de CVF au cours de la première heure était de 0,5 (IC 95 %, 0,3 à 0,6) L. On a observé une atélectasie visible chez 39 % des patients du groupe néostigmine et 29 % des patients du groupe sugammadex. La surface médiane [écart interquartile (EIQ)] d’atélectasie était de 9,7 [4,7–13,1] cm2 et 6,8 [3,6–12,5] cm2, respectivement.

Conclusion

Nous n’avons découvert aucune différence en ce qui touche à la fonction pulmonaire chez les patients neutralisés au sugammadex ou à la néostigmine dans une population à risque élevé.

Enregistrement de l’étude

EudraCT 2014-005156-26; enregistrée le 27 mai 2015.

Notes

Acknowledgements

Clinical investigators: Ana Aroca, Ana Gomez, Esther García-Villabona, Carmen Vallejo, Jesus Nieves, Ana Carmona, Diana Parrado, Rafael Morales.

Patient recruitment: Elena Rojo, Jara Torrente, Julia Hernando, Sonia Expósito, Elena Hernando, Marta Solera, David Arribas, Barbara Algar, Marina Valenzuela.

Provided care for study patients: General surgery department and operation room staff. Post-surgical critical care unit. University Hospital La Princesa, Madrid.

Conflicts of interest

None declared.

Editorial responsibility

This submission was handled by Dr. Gregory L. Bryson, Deputy Editor-in-Chief, Canadian Journal of Anesthesia.

Author contributions

Enrique Alday was involved in the promotion, study design, patient recruitment, spirometry and lung ultrasound, data collection, data analysis, and writing of the manuscript. Manolo Muñoz was involved in the study design, spirometry and lung ultrasound, data collection, offline lung ultrasound analysis, planimetry, and writing of the manuscript. Carlos Alvarez was involved in the study design, patient recruitment, data collection, and revising the manuscript. Esperanza Mata was involved in the study design, patient recruitment, data collection, and revising the manuscript. Antonio Planas was involved in the study design and writing of the manuscript.

Funding

This work was supported by a project grant from Merck Investigator Studies Program (MISP) (VT ID# 51875) of 70,490 euros.

The study was sponsored but not monitored by the company. Merck had no role in or authority over the study design; collection, management, analysis, and interpretation of data; writing of the report; or the decision to submit the report for publication. The opinions expressed in this publication are those of the authors and do not necessarily represent those of the financer.

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Copyright information

© Canadian Anesthesiologists' Society 2019

Authors and Affiliations

  1. 1.Hospital Universitario La PrincesaMadridSpain

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