Assessment of the safety and tolerance of 6% hydroxyethyl starch (200/0.5) solution: a randomized, controlled epidemiology study.

UNLABELLED: None of the natural and synthetic colloids currently available is free from the risk of side effects. This study was performed to contribute to the epidemiology of adverse reactions of the widely used 200/0.5 hydroxyethyl starch 6% solution (HES). Study end points were anaphylactoid reactions during preanesthesia infusion and perioperative course, and pruritus 5 days postoperatively (clinical examination and inquiry) and 8 wk after application (mailed patient questionnaire). We consecutively randomized 750 patients undergoing minor elective surgery into two parallel groups treated with HES (from two different manufacturers) and one control group treated with lactated Ringer's solution. The study population was well matched among the groups and consisted of patients of both sexes, aged 18-95 yr, ASA physical status I-III. No drug-related anaphylactoid reactions were detected during either of the observation intervals. There was no episode of pruritus after the fifth postoperative day. Incidence of pruritus after 8 wk was quite frequent but not significantly different (chi2 test, P = 0.77): 9.1% and 12.0% in the two HES groups and 11.5% in the lactated Ringer's solution control group. Except for pruritus, we conclude that HES was associated with no more complications than lactated Ringer's solution.

IMPLICATIONS: Anaphylactoid reactions and pruritus (itching) after the administration of a 6% hydroxyethyl starch (200/0.5) versus lactated Ringer's solution were assessed in a prospective, randomized, controlled study. There were no differences, although there was a more than 10% incidence of pruritus in both groups.