ROUTINE USE OF SUGAMMADEX DOES NOT SHORTEN PACU LENGTH OF STAY: A PROSPECTIVE DOUBLE-BLINDED RANDOMIZED CONTROLLED TRIAL

Germán Echeverry, Lily Polskin, Luis E Tollinche, Kenneth Seier, Kay See Tan, Patrick J McCormick, Gregory W Fischer, Florence M Grant, Germán Echeverry, Lily Polskin, Luis E Tollinche, Kenneth Seier, Kay See Tan, Patrick J McCormick, Gregory W Fischer, Florence M Grant

Abstract

Background: The reversal agent sugammadex has been shown to be more efficacious at reversal from neuromuscular blockade (NMB) induced by the aminosteroid class of non-depolarizing muscle relaxants than the traditionally used medication neostigmine. However, whether these differences lead to significantly faster PACU discharge readiness remains unknown. Given the increased acquisition cost of sugammadex as compared to neostigmine we compared these two reversal agents in our surgical population to determine if its pharmacokinetic superiority warranted a change in current practice.

Methods: We conducted a single-center randomized patient and assessor blinded clinical trial. A total of 201 patients presenting for surgery requiring NMB with an estimated duration of ≤ 6 hours were included in the intention-to-treat (ITT) analysis. The primary outcome was time from reversal agent administration to PACU discharge readiness, measured by either the institutional discharge scoring tool or bedside clinical assessment by a PACU physician or advanced practice provider. Secondary outcomes included subjective assessment of recovery by the patient (pain, visual changes, speaking difficulty, swallowing difficulty, PONV, anxiety) and a simple strength assessment.

Results: Median time from reversal administration to PACU discharge readiness was 3.59 hours (IQR 2.49-5.09) in the neostigmine group and 3.62 hours (IQR 2.70-5.87) in the sugammadex group. Patients who received sugammadex had 8% longer reversal to PACU discharge times (exp(estimate) 1.08, 95% CI [0.87-1.34], p=0.499). Patients age 70 or older had 28% longer reversal to PACU discharge times (exp(estimate) of 1.28, 95% CI [0.91-1.80], P=0.158). In the a modified ITT analysis, sugammadex patients were estimated to be in PACU 13% longer than neostigmine arm patients (exp(estimate) 1.13, 95% CI [0.91-1.40], p=0.265) and patients older than or equal to 70 years 31% longer than patients less than 70 years old (exp(estimate) 1.31, 95% CI [0.93-1.84], p=0.121). Treatment arm was not associated with any of the secondary outcomes.

Conclusion: There was no significant difference in time to readiness to discharge from PACU, and there were no subjective or objective clinically relevant differences in recovery from neuromuscular blockade between the groups. Findings of this study support continued use of either agent at the anesthesiologist's discretion.

Keywords: Neostigmine; Neuromuscular blockade; Sugammadex.

Conflict of interest statement

Conflict of interest statement: Dr. Echeverry - none. Mrs. Polskin - none. Dr. Tollinche serves as a paid consultant and has an advisory role for Merck. He is a grant recipient through Merck Investigator Studies Program to fund a clinical trial at Memorial Sloan Kettering Cancer Center (NCT03808077). Mr. Seier - none. Dr. Tan - none. Dr. McCormick - none. Dr. Fischer - none. Dr. Grant - none.

Figures

Figure 1.
Figure 1.
Patient’s Flowchart. Randomization and inclusion/exclusion. NMB, neuromuscular blocker.

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