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An event is serious (based on the ICH definition) when the patient outcome is:
* congenital anomaly
* other medically important event
In a case report, a 65-year-old man and a 29-year-old woman were described, who developed anaphylactic reaction during treatment with sugammadex [routes not stated].
Patient 1: The 65-year-old man, who underwent a levator muscle shortening surgery for ptosis, received general anaesthesia with rocuronium bromide, propofol and fentanyl and maintained with remifentanil and sevoflurane after tracheal intubation. Prior to skin incision, he received piperacillin, and after three hours of surgery, the anaesthetics were discontinued. Subsequently, sugammadex 100mg (1.2 mg/kg) was started. Three minutes later, he was conscious with regular breathing, and his trachea was extubated. He suddenly became severely hypotensive, cyanotic and unconscious five minutes after the extubation. He was...