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Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery.
Br J Anaesth. 2020 05; 124(5):553-561.BJ

Abstract

BACKGROUND

Residual neuromuscular block has been associated with postoperative pulmonary complications. We hypothesised that sugammadex reduces postoperative pulmonary complications in patients aged ≥70 yr having surgery ≥3 h, compared with neostigmine.

METHODS

Patients were enrolled in an open-label, assessor-blinded, randomised, controlled trial. At surgical closure, subjects were equally randomised to receive sugammadex 2 mg kg-1 or neostigmine 0.07 mg kg-1 (maximum 5 mg) for rocuronium reversal. The primary endpoint was incidence of postoperative pulmonary complications. Secondary endpoints included residual paralysis (train-of-four ratio <0.9 in the PACU) and Phase 1 recovery (time to attain pain control and stable respiratory, haemodynamic, and neurological status). The analysis was by intention-to-treat.

RESULTS

Of the 200 subjects randomised, 98 received sugammadex and 99 received neostigmine. There was no significant difference in the primary endpoint of postoperative pulmonary complications despite a signal towards reduced incidence for sugammadex (33% vs 40%; odds ratio [OR]=0.74; 95% confidence interval [CI]=[0.40, 1.37]; P=0.30) compared with neostigmine. Sugammadex decreased residual neuromuscular block (10% vs 49%; OR=0.11, 95% CI=[0.04, 0.25]; P<0.001). Phase 1 recovery time was comparable between sugammadex (97.3 min [standard deviation, sd=54.3]) and neostigmine (110.0 min [sd=62.0]), difference -12.7 min (95% CI, [-29.2, 3.9], P=0.13). In an exploratory analysis, there were fewer 30 day hospital readmissions in the sugammadex group compared with the neostigmine group (5% vs 15%; OR=0.30, 95% CI=[0.08, 0.91]; P=0.03).

CONCLUSIONS

In older adults undergoing prolonged surgery, sugammadex was associated with a 40% reduction in residual neuromuscular block, a 10% reduction in 30 day hospital readmission rate, but no difference in the occurrence of postoperative pulmonary complications. Based on this exploratory study, larger studies should determine whether sugammadex may reduce postoperative pulmonary complications and 30 day hospital readmissions.

CLINICAL TRIAL REGISTRATION

NCT02861131.

Authors+Show Affiliations

Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA. Electronic address: togioka@ohsu.edu.Department of Anesthesiology, Yale University, New Haven, CT, USA.Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA.Department of Anesthesiology and Perioperative Medicine, Oregon Health & Science University, Portland, OR, USA; Department of Anesthesiology, Yale University, New Haven, CT, USA.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32139135

Citation

Togioka, Brandon M., et al. "Randomised Controlled Trial of Sugammadex or Neostigmine for Reversal of Neuromuscular Block On the Incidence of Pulmonary Complications in Older Adults Undergoing Prolonged Surgery." British Journal of Anaesthesia, vol. 124, no. 5, 2020, pp. 553-561.
Togioka BM, Yanez D, Aziz MF, et al. Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery. Br J Anaesth. 2020;124(5):553-561.
Togioka, B. M., Yanez, D., Aziz, M. F., Higgins, J. R., Tekkali, P., & Treggiari, M. M. (2020). Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery. British Journal of Anaesthesia, 124(5), 553-561. https://doi.org/10.1016/j.bja.2020.01.016
Togioka BM, et al. Randomised Controlled Trial of Sugammadex or Neostigmine for Reversal of Neuromuscular Block On the Incidence of Pulmonary Complications in Older Adults Undergoing Prolonged Surgery. Br J Anaesth. 2020;124(5):553-561. PubMed PMID: 32139135.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Randomised controlled trial of sugammadex or neostigmine for reversal of neuromuscular block on the incidence of pulmonary complications in older adults undergoing prolonged surgery. AU - Togioka,Brandon M, AU - Yanez,David, AU - Aziz,Michael F, AU - Higgins,Janna R, AU - Tekkali,Praveen, AU - Treggiari,Miriam M, Y1 - 2020/03/02/ PY - 2019/11/21/received PY - 2020/01/26/revised PY - 2020/01/28/accepted PY - 2020/3/7/pubmed PY - 2020/5/10/medline PY - 2020/3/7/entrez KW - acetylcholinesterase inhibitor KW - cyclodextrin KW - neostigmine KW - neuromuscular block KW - pulmonary complications KW - rocuronium KW - sugammadex SP - 553 EP - 561 JF - British journal of anaesthesia JO - Br J Anaesth VL - 124 IS - 5 N2 - BACKGROUND: Residual neuromuscular block has been associated with postoperative pulmonary complications. We hypothesised that sugammadex reduces postoperative pulmonary complications in patients aged ≥70 yr having surgery ≥3 h, compared with neostigmine. METHODS: Patients were enrolled in an open-label, assessor-blinded, randomised, controlled trial. At surgical closure, subjects were equally randomised to receive sugammadex 2 mg kg-1 or neostigmine 0.07 mg kg-1 (maximum 5 mg) for rocuronium reversal. The primary endpoint was incidence of postoperative pulmonary complications. Secondary endpoints included residual paralysis (train-of-four ratio <0.9 in the PACU) and Phase 1 recovery (time to attain pain control and stable respiratory, haemodynamic, and neurological status). The analysis was by intention-to-treat. RESULTS: Of the 200 subjects randomised, 98 received sugammadex and 99 received neostigmine. There was no significant difference in the primary endpoint of postoperative pulmonary complications despite a signal towards reduced incidence for sugammadex (33% vs 40%; odds ratio [OR]=0.74; 95% confidence interval [CI]=[0.40, 1.37]; P=0.30) compared with neostigmine. Sugammadex decreased residual neuromuscular block (10% vs 49%; OR=0.11, 95% CI=[0.04, 0.25]; P<0.001). Phase 1 recovery time was comparable between sugammadex (97.3 min [standard deviation, sd=54.3]) and neostigmine (110.0 min [sd=62.0]), difference -12.7 min (95% CI, [-29.2, 3.9], P=0.13). In an exploratory analysis, there were fewer 30 day hospital readmissions in the sugammadex group compared with the neostigmine group (5% vs 15%; OR=0.30, 95% CI=[0.08, 0.91]; P=0.03). CONCLUSIONS: In older adults undergoing prolonged surgery, sugammadex was associated with a 40% reduction in residual neuromuscular block, a 10% reduction in 30 day hospital readmission rate, but no difference in the occurrence of postoperative pulmonary complications. Based on this exploratory study, larger studies should determine whether sugammadex may reduce postoperative pulmonary complications and 30 day hospital readmissions. CLINICAL TRIAL REGISTRATION: NCT02861131. SN - 1471-6771 UR - https://www.unboundmedicine.com/medline/citation/32139135/Randomised_controlled_trial_of_sugammadex_or_neostigmine_for_reversal_of_neuromuscular_block_on_the_incidence_of_pulmonary_complications_in_older_adults_undergoing_prolonged_surgery_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0007-0912(20)30071-4 DB - PRIME DP - Unbound Medicine ER -