Efficacy for BRIDION® (sugammadex)
Recovery in Special Patient Populations
Following rocuronium-induced NMB, choose BRIDION (sugammadex) to achieve rapid recovery.
Clinically relevant recovery is defined as a TOF ratio ≥0.91
BRIDION®
(sugammadex) injection 100 mg/mL (equivalent to 108.8 mg/mL sugammadex sodium), for intravenous use
Efficacy for BRIDION® (sugammadex)
Clinically relevant recovery is defined as a TOF ratio ≥0.91
aThere were 7 censored observations in the rocuronium group.
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).1,4 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.
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).1,7 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.
In a dedicated clinical study of geriatric patients (n=102) that compared the time to recovery from rocuronium-induced moderate neuromuscular blockade (NMB), BRIDION demonstrated time to recovery of the train-of-four (TOF) ratio to 0.9 comparable with other treatment groups.8
Multicenter, parallel-group, open-label study compared the efficacy of 2 mg/kg of BRIDION for reversal of rocuronium-induced moderate NMB (reappearance of T2) in 48 adult patients (18–64 years), 62 geriatric patients (65–74 years), and 40 older geriatric patients (≥75 years) (American Society of Anesthesiologists [ASA] class 1–3). The primary endpoint was the time from start of BRIDION administration to a TOF ratio (T4/ T1) of 0.9.
In an analysis of pooled clinical trial data, BRIDION demonstrated rapid reversal of rocuronium-induced deep NMB (TOF count of 0, 1–2 post-tetanic counts [PTCs]) to recovery of the TOF ratio to 0.9 in geriatric patients.
Explore other special patient populations
In a clinical study, BRIDION provided reversal of rocuronium-induced moderate NMB (reappearance of T2) to recovery of the TOF ratio to 0.9 in patients diagnosed with or having a history of cardiac disease.9
Multicenter, randomized, parallel-group, placebo-controlled, safety-assessor-blinded study compared the safety and efficacy of 2 mg/kg and 4 mg/kg of BRIDION for reversal of rocuronium-induced moderate NMB (reappearance of T2) in 76 patients who were diagnosed with or have a history of cardiac disease (e.g., patients with ischemic disease, chronic heart failure, or arrhythmia), primarily New York Heart Association (NYHA) Class II. The primary endpoint was to evaluate the safety of BRIDION 2 mg/kg and 4 mg/kg, with the time from start of BRIDION administration to a TOF ratio of 0.9 as a secondary endpoint.
Explore other special patient populations
In a clinical study, BRIDION achieved rapid reversal of rocuronium-induced moderate NMB (reappearance of T2) to recovery of the TOF ratio to 0.9 in patients diagnosed with or having a history of pulmonary complications.10
Multicenter, randomized, parallel-group, comparative, safety-assessor–blinded study compared the safety and efficacy of 2 mg/kg and 4 mg/kg of BRIDION for reversal of rocuronium-induced moderate NMB (reappearance of T2) in 77 patients who were diagnosed with or have a history of pulmonary complications (ASA class 2 and 3). The primary objective was to evaluate the safety of BRIDION 2 mg/kg and 4 mg/kg, with the time from start of BRIDION administration to a TOF ratio of 0.9 as a primary efficacy objective.
Explore other special patient populations
In a study of obese patients (n=188), BRIDION demonstrated statistically significantly faster recovery in patients dosed by ABW compared to IBW pooled across NMB (moderate or deep) and neuromuscular blocking agent (rocuronium or vecuronium).11
*Obese is defined as a BMI ≥40 kg/m2
Randomized, double-blind trial in 188 obese patients investigated the time to recovery from moderate or deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium. Patients received 2 mg/kg or 4 mg/kg BRIDION, as appropriate for level of block, dosed according to either ABW or IBW. The primary efficacy endpoint, time to recovery of TOF ratio ≥0.9, was compared for ABW vs IBW dosing, pooled across depth of block and NMBA.
The study was not designed for a comparative analysis on this exploratory endpoint and the exploratory results must be interpreted with caution.
Randomized, double-blind trial in 188 obese patients investigated the time to recovery from moderate or deep neuromuscular blockade (NMB) induced by rocuronium or vecuronium. Patients received 2 mg/kg or 4 mg/kg BRIDION, as appropriate for level of block, dosed according to either ABW or IBW. Pooled across depth of block and neuromuscular agent, the primary endpoint, i.e. the median time to recover to a TOF ratio ≥0.9 in patients dosed by ABW (1.8 minutes), was statistically significantly faster compared to the patients dosed by IBW (3.3 minutes). An exploratory endpoint of the study was to understand the distributions of recovery times for BRIDION and neostigmine in moderate depth of block pooled across NMBA.
Explore other special patient populations
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Recovery in Pediatric Patients
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Mechanism of Action for BRIDION® (sugammadex)
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.