Adverse events associated with the intraoperative injection of isosulfan blue.
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.


METHODS
Retrospective chart review.


METHODS
University-affiliated institution specializing in malignancies


METHODS
1835 patients representing a total of 1852 surgical procedures.


METHODS
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.


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.
Daley
M Denise
MD
Department of Anesthesiology, University of Texas M.D. Anderson Cancer Center, Houston, TX 77030, USA.
Norman
Peter H
PH
Leak
Jessie A
JA
Nguyen
Dy T
DT
Bui
Thao P
TP
Kowalski
Alicia M
AM
Srejic
Una
U
Popat
Keyuri
K
Arens
James F
JF
Gershenwald
Jeffrey E
JE
Hunt
Kelly K
KK
Kuerer
Henry M
HM
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D002648:Child; D002675:Child, Preschool; D005260:Female; D006801:Humans; D007267:Injections; D007432:Intraoperative Period; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D012307:Risk Factors; D012394:Rosaniline Dyes / Q000009:adverse effects*; D013997:Time Factors
D012394:Rosaniline Dyes; C025484:iso-sulfan blue