Key result
Intravenous sugammadex at 16 mg/kg in healthy subjects resulted in limited, transient increases in APTT (geometric mean ratio 1.019; 95% CI 0.868-1.195) and PT(INR).
Why the study?
Does sugammadex prolong APTT and PT(INR) in healthy subjects?
Population
8 healthy subjects (18 - 45 years of age)
Comparison
Intravenous doses of 4 mg/kg sugammadex or 16… vs Placebo
Design
RCT, randomized, three period cross-over, placebo-controlled
Follow-up
60 minutes post-dose
Authors
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No coagulation monitoring needed for high-dose sugammadex in healthy subjects; confirms minimal effects in RCT data.
RCT (n=8)
randomized
Does sugammadex prolong APTT and PT(INR) in healthy subjects?
Effect estimate: Geometric mean ratio 1.019 (for APTT at 16 mg/kg) (95% CI 0.868-1.195)
Administration of sugammadex is associated with a dose-related, limited and transient prolongation of APTT and PT(INR) that is unlikely to be of clinical relevance.
Kam et al. (2014) conducted an RCT in Healthy (n=8). Sugammadex vs. Placebo was evaluated on Area under the curve from 2 to 60 minutes post-dose (AUC2-60min) for APTT and PT(INR) (Geometric mean ratio 1.019 (for APTT at 16 mg/kg), 95% CI 0.868-1.195). Intravenous sugammadex at 16 mg/kg in healthy subjects resulted in limited, transient increases in APTT (geometric mean ratio 1.019; 95% CI 0.868-1.195) and PT(INR).
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