A randomized simultaneous comparison of acceleromyography with a peripheral nerve stimulator for assessing reversal of rocuronium-induced neuromuscular blockade with sugammadex.

BACKGROUND AND OBJECTIVE: We investigated the relationship between acceleromyography and a peripheral nerve stimulator for measuring reversal in patients administered sugammadex following rocuronium. METHODS: In this randomized, active and within-participant controlled study, patients received rocuronium 0.6 mg kg for intubation with 0.15 mg kg maintenance doses as required. Single-dose sugammadex 4.0 or 1.0 mg kg was given 15 min after the last rocuronium dose. Neuromuscular monitoring was performed simultaneously: acceleromyography on one forearm and a peripheral nerve stimulator on the other. The peripheral nerve stimulator assessor was blinded to acceleromyography results. The primary efficacy end point was the difference between time from start of sugammadex 4.0 mg kg administration to recovery of the train-of-four ratio to 0.9 (acceleromyography) and time to reappearance of the fourth twitch (T4) (peripheral nerve stimulator). RESULTS: Sixty-one patients received sugammadex 4.0 mg kg. With acceleromyography, mean (SD) recovery time to a train-of-four ratio of at least 0.9 was 1.5 (0.7) min. With both the peripheral nerve stimulator and acceleromyography, mean (SD) time to T4 reappearance was 0.8 (0.3) min. Mean (95% confidence interval) difference between time to T4 reappearance (peripheral nerve stimulator) and recovery to a train-of-four ratio of at least 0.9 (acceleromyography) was 0.8 (0.6-0.9) min. CONCLUSION: T4 is detected at similar times when measured by a peripheral nerve stimulator or acceleromyography following sugammadex 4.0 mg kg administration 15 min after rocuronium. The mean interval between T4 reappearance (peripheral nerve stimulator) and recovery to a train-of-four ratio of at least 0.9 (acceleromyography) was 0.8 min. These findings provide guidance for evaluating the reversal effect of sugammadex in clinical situations.

Early reversal of profound rocuronium-induced neuromuscular blockade by sugammadex in a randomized multicenter study: efficacy, safety, and pharmacokinetics.

BACKGROUND: Sugammadex reverses the neuromuscular blocking effects of rocuronium by chemical encapsulation. The efficacy, safety, and pharmacokinetics of sugammadex for reversal of profound rocuronium-induced neuromuscular blockade were evaluated. METHODS: Ninety-eight male adult patients were randomly assigned to receive sugammadex (1, 2, 4, 6, or 8 mg/kg) or placebo at 3, 5, or 15 min after 0.6 mg/kg rocuronium. Patients were anesthetized with propofol and fentanyl. The primary endpoint of the study was the time to achieve a recovery of train-of-four ratio to 0.9. Neuromuscular blockade was measured using acceleromyography. Concentrations of rocuronium and sugammadex were determined in venous blood and urine samples. A population pharmacokinetic model using NONMEM (GloboMax LLC, Hanover, MD) was applied. RESULTS: The mean time to recovery of the train-of-four ratio to 0.9 after dosing at 3, 5, and 15 min decreased from 52.1, 51.7, and 35.6 min, respectively, after administration of placebo to 1.8, 1.5, and 1.4 min, respectively, after 8 mg/kg sugammadex. Sugammadex was safe and well tolerated. However, 20.4% of patients showed signs of inadequate anesthesia after its administration. The median cumulative excretion of rocuronium in the urine over 24 h was 26% in the placebo group and increased to 58-74% after 4-8 mg/kg sugammadex. The mean plasma clearances of sugammadex and rocuronium were 0.084 and 0.26 l/min, respectively. CONCLUSIONS: In male subjects, sugammadex safely reversed profound neuromuscular blockade induced by 0.6 mg/kg rocuronium in a dose-dependent manner. Sugammadex enhanced the renal excretion of rocuronium, and its clearance is approximately one third that of rocuronium.