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Was It a True Emergency?

Section Editor(s): Saidman, LawrenceZiser, Avishai MD

doi: 10.1213/01.ane.0000268704.80213.fe
Letters to the Editor: Letters & Announcements
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Department of Anesthesiology; Rambam Medical Center; Haifa, Israel; aziser@rambam.health.gov.il

The FDA does not wish to respond.

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To the Editor:

Lenz et al. (1) describe a case of emergency use of sugammadex to treat residual neuromuscular blockade in a patient with end stage renal disease, who received vecuronium. An editorial in the same issue describes criteria for emergency use of an investigational drug (2). The four criteria include, briefly: life-threatening situation; inability to obtain informed consent; no sufficient time for a consent form; and no alternative method of approved or recognized therapy that provides an equal or greater likelihood of saving life. Residual neuromuscular blockade is not an uncommon problem in anesthesia practice. Since the patient's trachea was intubated, his lungs could be easily manually or mechanically ventilated and another attempt at separation for the ventilator could be commenced within an hour. Returning to the four criteria, this patient was not in a life-threatening situation and there was a safe, simple and commonly used alternative therapy (mechanical-ventilation). I am also concerned about the decision to discharge that patient within 2 h. Sugammadex has a half life of 100 min and it is mainly excreted in the kidneys (3). Its effect was not studied in patients with end stage renal disease and therefore a more prolonged post extubation observation period was required. It is also worth remembering that sugammadex was studied mainly as a reversal agent of rocuronium and not vecuronium. This adds another factor of uncertainty to that case and stresses the importance of a longer postoperative observation before discharge.

Avishai Ziser, MD

Department of Anesthesiology

Rambam Medical Center

Haifa, Israel

aziser@rambam.health.gov.il

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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. Schultheis LW, Rapopport BA. The Food and Drug Administration perspective: use of an investigational drug in medical emergency. Anesth Analg 2007;104:479–80
3. Gijsenbergh F, Ramael S, Houwing N, Van Iersel T. First human exposure of ORG 25969, a novel agent to reverse the action of rocuronium bromide. Anesthesiology 2005;103:695–703
© 2007 International Anesthesia Research Society