Incidence of anaphylactoid reactions to isosulfan blue dye during breast carcinoma lymphatic mapping in patients treated with preoperative prophylaxis: results of a surgical prospective clinical practice protocol.

BACKGROUND: Severe anaphylactoid reactions to isosulfan blue dye requiring resuscitation are reported to occur in 1.1% of patients with breast carcinoma undergoing sentinel lymphadenectomy. In December 2001, the authors began administering a prophylactic regimen before dye injection to determine whether prophylaxis reduced the incidence of life-threatening reactions. METHODS: All patients were mapped with technetium-99m-labeled sulfur colloid. Those also receiving isosulfan blue dye were administered a glucocorticoid, diphenhydramine, and famotidine intravenously just before or at induction of anesthesia. Adverse reactions at the time of surgery were analyzed. RESULTS: Between December 2001 and July 2003, 1013 consecutive patients underwent sentinel lymphadenectomy for breast carcinoma. Six hundred sixty-seven patients (65.8%) received prophylaxis and isosulfan blue dye, 33 (3.3%) received prophylaxis but no dye, 12 (1.2%) received dye but no prophylaxis, and 301 (29.7%) received no prophylaxis or dye. Blue urticaria and facial edema were observed in 3 (0.5%) of 667 patients receiving prophylaxis and dye and in 1 (8.3%) of 12 patients receiving dye but no prophylaxis. There were no episodes of hypotension, and no patients required vasopressors, ventilatory support, or intensive care observation. Adverse reactions to agents other than blue dye were observed in 2 (0.3%) of 667 patients receiving prophylaxis and dye and in 3 (1.0%) of 301 receiving no prophylaxis and no dye (P = 0.1773). CONCLUSIONS: Preoperative prophylaxis was found to reduce the severity, but not the overall incidence, of adverse reactions to isosulfan blue dye. No life-threatening reactions were noted in patients treated with preoperative prophylaxis. Based on these results, the authors now routinely recommend administration of prophylaxis to patients receiving isosulfan blue for lymphatic mapping and sentinel lymph node biopsy.

Adverse events associated with the intraoperative injection of isosulfan blue.

STUDY OBJECTIVE: To describe the adverse events associated with the intraoperative injection of isosulfan blue in a large group of patients having a wide range of surgical procedures, and to identify risk factors for these events. DESIGN: Retrospective chart review. SETTING: University-affiliated institution specializing in malignancies PATIENTS: 1835 patients representing a total of 1852 surgical procedures. MEASUREMENTS: Incidence, type, severity, onset time, duration, management, and the presence of potential risk factors for adverse events. Events were considered "major" if potentially life-threatening hypotension occurred. MAIN RESULTS: Adverse events occurred in 28 procedures (1.5%) and 14 of these adverse events (0.75%) were classified as major. The types of events were: skin reactions in 21 patients, hypotension in 14 patients, edema in 1 patients, and unspecified in 1 patient. The time of onset for adverse events was 42.2 +/- 53.9 minutes (median, 17.5; range, 1 to 180 min) after isosulfan blue injection, and was significantly longer for minor reactions compared with major events (p = 0.015). The longest adverse event lasted at least 21 hours. Treatment was successful with usual antiallergy/antianaphylaxis medications. Ten patients received diphenhydramine alone, and four patients received intravenous epinephrine infusions. Factors associated with a significantly increased incidence of adverse events were isosulfan blue injection in the vulvar area (p = 0.000038), and the chronic preoperative use of angiotensin-converting enzyme inhibitors or angiotensin receptor-blocking agents (p = 0.043). Trends toward an increased risk of an adverse event were noted with isosulfan blue injection in the breast area (p = 0.19), and having more than one surgical procedure with isosulfan blue (p = 0.14). CONCLUSIONS: Although the most frequent adverse event associated with injection of isosulfan blue was a skin reaction, potentially life-threatening hypotension occurred in 0.75% of all procedures. Anesthesiologists must be aware of the variable onset time and potentially prolonged duration of the adverse events. They should recognize the need for extra vigilance in patients with potential risk factors, and have the usual antiallergy/antianaphylaxis medications available for administration if necessary.