Sugammadex Use in Chronic Kidney Disease
Sugammadex can be used safely and effectively in patients with CKD, including those with severe renal impairment and end-stage renal disease (ESRD), though the FDA label advises against use when eGFR <30 mL/min due to prolonged drug exposure and limited safety data. 1
FDA Labeling and Pharmacokinetic Considerations
The FDA-approved label for sugammadex (Bridion) states it is "not recommended" for patients with severe renal impairment, as sugammadex is >90% renally excreted unchanged 1. However, this recommendation is based primarily on pharmacokinetic concerns rather than documented adverse outcomes:
- Moderate renal impairment (CrCl 30-50 mL/min): Sugammadex exposure increases 2.4-fold with clearance progressively decreasing, but no dose adjustment is required 2
- Severe renal impairment (CrCl <30 mL/min): Exposure increases 5-17 fold with elimination half-life prolonged to 19 hours (versus 2 hours in normal renal function), and low concentrations remain detectable for at least 48 hours to 7 days post-dose 1, 2
Clinical Evidence Supporting Use in Severe CKD/ESRD
Despite FDA labeling, emerging clinical evidence demonstrates sugammadex is both safe and effective in patients with severe renal impairment:
Most recent high-quality evidence: A 2024 randomized, double-blinded trial in patients with CrCl <30 mL/min showed sugammadex 2 mg/kg reversed rocuronium-induced neuromuscular blockade significantly faster than neostigmine reversing cisatracurium (mean 3.5 minutes vs 14.8 minutes to TOFR ≥90%), with no major adverse events 3. This represents an 11.3-minute faster recovery (95% CI: 9.0-13.5 minutes) 3.
Real-world safety data: A 2020 two-center retrospective study of 158 surgical patients with ESRD requiring pre-operative dialysis found no cases of recurrence of neuromuscular blockade or re-intubation due to residual blockade after sugammadex administration 4. Notably, 18% of these patients had failed neostigmine reversal but achieved successful extubation after sugammadex 4.
Current practice patterns: A 2025 multicenter registry analysis of 243,944 cases showed rocuronium-sugammadex use in patients with eGFR <60 mL/min increased from 4.4% to 95.2% between 2016-2022, including patients with eGFR <15 mL/min where use increased from 0.5% to 86.9% 5. This dramatic shift reflects real-world clinical acceptance despite FDA labeling 5.
Practical Recommendations for CKD Patients
Mild to Moderate CKD (eGFR 30-60 mL/min)
- Use standard sugammadex dosing (2 mg/kg for moderate block, 4 mg/kg for deep block) without adjustment 1, 2
- Monitor neuromuscular function with quantitative monitoring (electromyography preferred) to confirm TOFR ≥90% before extubation 3, 6
Severe CKD/ESRD (eGFR <30 mL/min)
- Sugammadex can be used when clinically indicated, particularly when rapid, complete reversal is essential or when neostigmine has failed 3, 4
- Administer standard doses (2-4 mg/kg based on depth of block) 1, 3
- Mandatory quantitative neuromuscular monitoring is essential to document complete reversal (TOFR ≥90%) before extubation 6
- Maintain ventilatory support until adequate spontaneous respiration is confirmed and airway patency is assured 1
- Consider extended post-operative monitoring given prolonged drug half-life (up to 19 hours) 1, 2
- For patients on dialysis, timing of post-operative dialysis does not require specific adjustment, as sugammadex-rocuronium complexes are removed by dialysis 4
Critical Pitfalls to Avoid
Do not withhold sugammadex solely based on renal function when it is the most appropriate reversal agent, as the alternative (neostigmine) may be less effective and carries its own risks in CKD patients 3, 4. The evidence shows sugammadex provides superior neuromuscular recovery even in severe renal impairment 3.
Never extubate without objective confirmation of adequate reversal using quantitative neuromuscular monitoring showing TOFR ≥90%, as subjective clinical assessment is unreliable 6. This is particularly critical in CKD patients where drug clearance is impaired 1.
Avoid assuming recurarization will occur based solely on pharmacokinetic data—clinical studies have not demonstrated recurrence of neuromuscular blockade in ESRD patients when adequate initial reversal is confirmed 4, 6.
Monitor for bradycardia within minutes after sugammadex administration, as marked bradycardia and rare cardiac arrest have been reported; have atropine immediately available 1.
Medication Interactions in CKD Context
Temporarily withhold sugammadex during prolonged fasting, surgery preparation, or critical illness in patients also taking SGLT2 inhibitors, as both medications may need to be held peri-operatively 7, 1. Patients using hormonal contraceptives must use additional non-hormonal contraception for 7 days following sugammadex administration 1.