Efficacy for BRIDION® (sugammadex)
Recovery from moderate and deep block
Following rocuronium-induced moderate NMB, BRIDION demonstrated rapid recovery to a TOF Ratio of 0.9
BRIDION®
(sugammadex) injection 100 mg/mL (equivalent to 108.8 mg/mL sugammadex sodium), for intravenous use
Efficacy for BRIDION® (sugammadex)
Following rocuronium-induced moderate NMB, BRIDION demonstrated rapid recovery to a TOF Ratio of 0.9
Multicenter, randomized, parallel-group, active-controlled, safety-assessor–blinded study compared the efficacy of 2 mg/kg of BRIDION vs 50 μg/kg of neostigmine and 10 μg/kg of glycopyrrolate for reversal of rocuronium- or vecuronium-induced moderate NMB (reappearance of T2) in 189 patients (87 women and 102 men, ASA majority class 1,2). Patients underwent elective procedures that were mainly endocrine; ocular; ear, nose, and throat; abdominal (gynecological, colorectal, urological); orthopedic; vascular; or dermatological in nature. An objective monitoring device (TOF-Watch® SX) was used to evaluate neuromuscular function, to measure the depth of block based on responses to TOF stimulation (TOF count or twitches), and to calculate the degree of recovery using TOF ratio (which cannot be calculated without an objective monitoring device).2,5 The primary endpoint was the time from start of BRIDION or neostigmine administration to a TOF ratio of 0.9, which generally correlates with recovery from NMB.
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Recovery from moderate block
BRIDION (sugammadex) achieved rapid recovery from moderate block following rocuronium- and vecuronium-induced neuromuscular blockade (NMB).
In a clinical study, BRIDION demonstrated significantly faster reversal of rocuronium-induced moderate NMB (reappearance of T2) to recovery of the train-of-four (TOF) ratio to 0.9 vs neostigmine.3
Vecuronium: Median time from vecuronium-induced moderate NMB to a TOF ratio of 0.9 was 2.1 minutes following administration of 2 mg/kg of BRIDION (Quartiles [Q1, Q3]: 1.8, 3.4 minutes; n=48) vs a median time of 29.0 minutes (Quartiles [Q1, Q3]: 12.2, 76.2 minutes; n=45) following administration of 50 μg/kg of neostigmine and 10 μg/kg of glycopyrrolate.4
Multicenter, randomized, parallel-group, active-controlled, safety-assessor–blinded study compared the efficacy of 2 mg/kg of BRIDION vs 50 μg/kg of neostigmine and 10 μg/kg of glycopyrrolate for reversal of rocuronium- or vecuronium-induced moderate NMB (reappearance of T2) in 189 patients (87 women and 102 men, ASA majority class 1,2). Patients underwent elective procedures that were mainly endocrine; ocular; ear, nose, and throat; abdominal (gynecological, colorectal, urological); orthopedic; vascular; or dermatological in nature. An objective monitoring device (TOF-Watch® SX) was used to evaluate neuromuscular function, to measure the depth of block based on responses to TOF stimulation (TOF count or twitches), and to calculate the degree of recovery using TOF ratio (which cannot be calculated without an objective monitoring device).2,5 The primary endpoint was the time from start of BRIDION or neostigmine administration to a TOF ratio of 0.9, which generally correlates with recovery from NMB.
Recovery from deep block
BRIDION (sugammadex) provided rapid recovery from deep block.
In a clinical study, BRIDION demonstrated rapid recovery from rocuronium-induced deep NMB (1-2 post-tetanic counts [PTCs]) to recovery of the train-of-four (TOF) ratio to 0.9.6
Most patients who received BRIDION recovered to a TOF ratio (T4/T1) of 0.9 within 5 minutes from the start of administration.6 Generally, a TOF ratio ≥0.9 correlates with recovery from NMB.
Vecuronium: Median time from vecuronium-induced deep NMB to a TOF ratio of 0.9 was 3.3 minutes following administration of 4 mg/kg of BRIDION (Quartiles [Q1, Q3], 2.3, 6.6 minutes; n=47). The median time from deep block was similar to the moderate block study, although a wider range was observed. Neostigmine was not expected to reverse NMB at a depth of 1–2 PTCs. There were 6 censored observations in the vecuronium group.
Multicenter, randomized, parallel-group, active-controlled, safety-assessor–blinded study compared the efficacy of 4 mg/kg of BRIDION vs 70 μg/kg of neostigmine and 14 μg/kg of glycopyrrolate for reversal of rocuronium- or vecuronium-induced deep NMB (1–2 PTCs) in 157 patients (86 women and 71 men, American Society of Anesthesiologists class 1–3). Patients underwent elective surgical procedures that were mainly abdominal (gynecological, colorectal, urological), orthopedic, reconstructive, or neurological in nature. An objective monitoring device (TOF-Watch® SX) was used to evaluate neuromuscular function, to measure the depth of block based on responses to TOF or PTC stimulation, and to calculate the degree of recovery using TOF ratio (which cannot be calculated without an objective monitoring device).2,8 The primary endpoint was the time from start of BRIDION or neostigmine administration to recovery of a TOF ratio of 0.9, which generally correlates with recovery from NMB.
Minimum Waiting Time | NMBA and Dose to be Administered |
---|---|
5 minutes | 1.2 mg/kg rocuronium |
4 hours | 0.6 mg/kg rocuronium or 0.1 mg/kg vecuronium |
If neuromuscular blockade is required before the recommended waiting time has elapsed, use a nonsteroidal neuromuscular blocking agent.