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Urgent Usage of Sugammadex to Treat Residual Neuromuscular Blockade in the PACU

Section Editor(s): Saidman, LawrenceJones, Philip M. MD, FRCPC; Turkstra, Timothy P. MD, FRCPC

doi: 10.1213/01.ane.0000268705.04400.10
Letters to the Editor: Letters & Announcements
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Department of Anesthesia and Perioperative Medicine; University Hospital; London Health Sciences Centre; London, Ontario; Canada

The FDA does not wish to respond.

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To the Editor:

Lenz et al. (1) describe a case wherein sugammadex was used urgently to rapidly restore full neuromuscular function in a patient with apparent inadequate reversal of residual neuromuscular blockade upon leaving the operating room. Vecuronium was used intraoperatively despite the fact that the patient had severe renal failure in which context vecuronium could be expected to have a prolonged half-life (2). After reversal with neostigmine and glycopyrrolate, “four twitches” were present, and the patient was noted to have “small tidal volumes.” Although sugammadex was quite effective, it is not yet an approved drug, and the authors justify its use under provisions of the IRB for emergency use of an investigational drug on a one-time only basis.

We have a concern about the use of sugammadex in this situation. The patient was still tracheally intubated and the simplest management would have been sedation and mechanical ventilation until fully intact neuromuscular function could be verified. Although sugammadex appears to be a safe drug, exposing the patient to an investigational drug without informed consent when there is a very effective and simple alternative needlessly places the patient at increased risk (however small the risk may be).

We are also perplexed that the authors discharged the patient home after only 2 h when he had been given an investigational drug whose pharmacokinetics have not been elucidated in patients with severe renal failure. Although sugammadex binds avidly to rocuronium and vecuronium, the risk of recurarization in the context of severe renal failure is currently unknown, and it would have been prudent to monitor the patient for a longer period of time.

The accompanying editorial (3) states that using an investigational drug outside of a clinical trial is only appropriate when “immediate use of the investigational drug is required to preserve the life of the patient and time is insufficient for an independent physician to certify the decision before treatment” (emphasis ours). In this situation, immediate use of sugammadex was not required to preserve the life of the patient, and this case could have been managed in a simpler, and possibly safer, fashion.

Philip M. Jones, MD, FRCPC

Timothy P. Turkstra, MD, FRCPC

Department of Anesthesia and Perioperative Medicine

University Hospital

London Health Sciences Centre

London, Ontario

Canada

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REFERENCES

1. Lenz A, Hill G, White PF. Emergency use of sugammadex after failure of standard reversal drugs. Anesth Analg 2007;104:585–6
2. Lynam DP, Cronnelly R, Castagnoli KP, Canfell PC, Caldwell J, Arden J, Miller RD. The pharmacodynamics and pharmacokinetics of vecuronium in patients anesthetized with isoflurane with normal renal function or with renal failure. Anesthesiology 1988;69:227–31
3. Schultheis LW, Rappaport BA. The Food and Drug Administration perspective: use of an investigational drug in a medical emergency. Anesth Analg 2007;104:479–80
© 2007 International Anesthesia Research Society