Where's the Fire?

Abstract

In Response: These four letters (1–4) all raise similar objections to our administration of sugammedex an investigational neuromuscular reversal drug, to a nonconsented patient who exhibited clinically significant muscle paralysis in the recovery room following unsuccessful reversal of a vecuronium-induced block with the maximum recommended dose (5 mg) of neostigmine (5). Drs. Rosman (1), Ziser (2), and Jones and Turkstra (3) also criticized our use of vecuronium in a patient with renal insufficiency. Finally, these correspondents all felt that we should have sedated the patient and mechanically ventilated his lungs in the postanesthesia care unit until he had spontaneously recovered from the residual neuromuscular blockade. In our view, vecuronium is a perfectly acceptable choice in a patient with compromised renal function but normal hepatic function, who is undergoing a 1–2 h operation, where at most only a very modest prolongation of its neuromuscular blocking effects would be expected (6). Sedating patients in the recovery room and providing mechanical ventilatory support is not without significant attendant risks (e.g., agitation, main stem tracheal intubation, pneumothorax), as well as additional costs to the patient and the healthcare system. Importantly, we carefully followed our institutional policy on emergency use of an investigational drug since the FDA policy statement (7) had obviously not been written at the time we rendered care to this patient. Sugammadex, has been extensively studied in both human volunteers and surgical patients without any unusual or unexpected side effects being reported to date (data on file with Organon USA, Inc.). Although allergic reactions (1) are always a possibility with any new drug, they are exceedingly rare in modern anesthesia practice. In fact, clinical use of sugammadex to date has been associated with a very impressive safety profile (8). A recent comparative study involving sugammadex and two commonly used reversal drug combinations, found significantly fewer side effects after surgery in patients reversed with the investigational compound (9). Naguib (10) points out that elimination of the sugammadex-muscle relaxant complex does not appear to rely on renal excretion. Thus, we do not agree with Drs. Ziser's, Jones' and Turkstra's concern about discharging this patient after a 2+ h observation period. From a medical perspective, it was not necessary to further extend the patient's length of stay in the day-surgery unit beyond 2 h because he was fully recovered from anesthesia and was insisting on being allowed to return to his home. The objections of these correspondents' nonwithstanding, we still feel that this case was an appropriate use of sugammadex. Although we anticipated that some of our colleagues would criticize the management of this patient, we felt it was important to publish this case report (5) to provide clinicians with important information that could not be obtained without intentionally putting patients at risk from residual postoperative neuromuscular paralysis. Fortunately, our patient was extremely appreciative of the fact that we had intervened with this experimental drug to alleviate the extremely uncomfortable symptoms he experienced in the early postoperative period. The patient also agreed to contact us when he arrived home after discharge, as well as the following day to report any untoward postoperative side effects. In summary, we feel that this case report (5) provides clinicians with important new information which would not have otherwise been known when this investigational drug becomes available for widespread clinical use. Our observation that sugammadex can rapidly and effectively reverse residual paralysis produced by a steroid-based nondepolarizing muscle relaxant when standard reversal drugs fail will hopefully result in fewer patients having to experience the uncomfortable and extremely anxiety-provoking symptoms associated with residual neuromuscular blockade upon awakening from general anesthesia in the future. Paul F. White, PhD, MD, FANZCA Professor and Holder of the Margaret Milam McDermott Distinguished Chair of Anesthesiology Department of Anesthesiology and Pain Management University of Texas Southwestern Medical Center Dallas, Texas [email protected] Gary Hill, MD, PhD Professor of Anesthesiology and Pain Management Department of Anesthesiology and Pain Management University of Texas Southwestern Medical Center Dallas, Texas Adam Lenz, MD Resident in Anesthesiology Department of Anesthesiology and Pain Management University of Texas Southwestern Medical Center Dallas, Texas