Sugammadex Safety in Dialysis Patients
Sugammadex can be used safely and effectively in patients with end-stage renal disease on dialysis, though it is not officially recommended by the FDA for this population. 1
Guideline Recommendations
The 2020 Anaesthesia guidelines recommend administering sugammadex at the usual dose in patients with renal failure (GRADE 2+, Strong Agreement). 2 While sugammadex is eliminated renally and accumulates in renal failure patients, clinical studies have demonstrated acceptable safety and efficacy profiles. 2
FDA Labeling Position
The FDA label explicitly states that sugammadex is not recommended for use in patients with severe renal impairment, including those requiring dialysis. 1 This creates a discrepancy between regulatory guidance and clinical practice guidelines, which you must navigate based on clinical necessity.
Clinical Evidence Supporting Use
Efficacy Data
Recovery time from neuromuscular blockade is rapid and effective in ESRD patients, with mean time to TOF ratio 0.9 of approximately 2.0 minutes in renal failure patients versus 1.65 minutes in controls (not statistically significant). 3
A two-center retrospective study of 158 ESRD patients (30% renal transplant, 70% other surgeries) showed no cases of recurrence of neuromuscular blockade. 4
A historical cohort of 219 ESRD patients receiving sugammadex demonstrated no hypersensitivity reactions and no complications attributable to sugammadex use. 5
Safety Profile
No recurrence of neuromuscular blockade was observed in any of the major clinical studies in ESRD patients. 4, 5, 3
Reintubation rates were not related to sugammadex in the studies that reported this outcome; when reintubation occurred, it was due to pulmonary edema from volume overload or worsening sepsis, not residual neuromuscular blockade. 4
Sugammadex successfully reversed incomplete neuromuscular blockade in 24 patients (18%) who had failed neostigmine reversal. 4
30-day mortality (4%) and postoperative complications (23%) in the cohort study were not attributable to sugammadex administration. 5
Pharmacokinetic Considerations
Sugammadex exposure increases substantially in renal impairment:
- 2.42-fold increase in moderate renal impairment (CrCl 30-50 mL/min) 6
- 5.42-fold increase in severe renal impairment (CrCl <30 mL/min) 6
Despite this accumulation, the drug complex (sugammadex-rocuronium) remains pharmacologically inactive and clinical recovery times remain acceptable. 3
Coagulation Concerns
Sugammadex doses up to 16 mg/kg can prolong aPTT and PT/INR by up to 25% for up to 1 hour. 1 However, in major orthopedic surgery patients receiving heparin or low molecular weight heparin thromboprophylaxis, increases were modest (5.5% aPTT, 3.0% PT/INR) with 4 mg/kg dosing. 1
Monitor coagulation parameters carefully if the patient:
- Has known coagulopathies 1
- Is receiving therapeutic anticoagulation 1
- Requires the 16 mg/kg immediate reversal dose 1
Practical Clinical Algorithm
When rocuronium is the only available non-depolarizing NMBA (as in some countries):
Use standard sugammadex dosing (2 mg/kg for moderate block at T2 reappearance, 4 mg/kg for deep block at 1-2 post-tetanic counts). 2
Perform quantitative neuromuscular monitoring (acceleromyography or electromyography) to confirm TOF ratio ≥0.9 before extubation. 7
Monitor for at least 30 minutes post-reversal for any signs of recurarization, though this has not been observed in clinical studies. 4, 5
Ensure dialysis is available postoperatively if needed, though the sugammadex-rocuronium complex is pharmacologically inactive. 3
Avoid the 16 mg/kg immediate reversal dose unless absolutely necessary, as safety data are more limited at this dose in ESRD. 1
Critical Caveats
Recovery may be slightly slower in ESRD patients compared to those with normal renal function, though the difference is clinically minor. 7, 3
Long-term safety data remain limited, particularly regarding potential accumulation with repeated exposures. 7
The FDA contraindication creates medicolegal considerations that require documentation of clinical necessity and informed decision-making. 1
Benzylisoquinolinium compounds (atracurium/cisatracurium) remain the preferred neuromuscular blocking agents in renal failure when available, as they undergo organ-independent elimination. 2