Prevention by ambroxol of bronchopulmonary complications after upper abdominal surgery: double-blind Italian multicenter clinical study versus placebo.

A double-blind multicenter study was carried out to evaluate the effectiveness of ambroxol, a drug able to promote surfactant synthesis, in the prevention of postoperative bronchopulmonary complications. A total of 252 patients with chronic obstructive lung disease (COLD) undergoing upper abdominal surgery were randomly allocated to receive either 1 g/day of ambroxol intravenously for 6 consecutive days in the perioperative period or placebo. Pulmonary complications were evaluated by clinical studies, radiographic, and blood gas analysis. There was a significant difference in atelectasis between the 2 groups (10.6% ambroxol vs 23.9% placebo). In addition, analysis of variance showed that the PaO2 values of the ambroxol-treated group after surgery decreased less than those of the placebo-treated group (p less than 0.05) from the preoperative values. The treatment was well tolerated, although nausea was significantly more frequent in the ambroxol-treated group. We think that ambroxol should be considered as an alternative and new pharmacologic approach for the prevention of postoperative pulmonary complications.

RCT Entities:   Population Interventions Outcomes