Use of sugammadex in patients with a history of pulmonary disease.

STUDY OBJECTIVE

To evaluate the safety and efficacy of sugammadex for reversal of rocuronium-induced neuromuscular blockade in patients with pulmonary disease.

DESIGN

Phase III, randomized, multicenter, parallel-group, comparative, safety-assessor blinded study.

SETTING

Nine hospital sites.

PATIENTS

77 ASA physical status 2 and 3 patients, aged ≥ 18 years, with a history of pulmonary disease, and scheduled for surgery with general anesthesia requiring neuromuscular blockade.

INTERVENTIONS

Following anesthesia induction, patients received rocuronium 0.6 mg/kg with 0.15 mg/kg maintenance doses as needed. Patients were randomized to receive sugammadex 2 mg/kg or 4 mg/kg after the last rocuronium dose at reappearance of the second twitch.

MEASUREMENTS

Safety evaluations included adverse events, laboratory parameters, vital signs, and evidence of recurrent or residual neuromuscular blockade. Efficacy was evaluated as the time from sugammadex administration to recovery of the train-of-four (TOF) ratio to ≥ 0.9.

MAIN RESULTS

Safety was comparable between doses, with no evidence of residual or recurrent neuromuscular blockade. Two bronchospasm cases were reported (4 mg/kg group), both in patients with asthma who received desflurane for anesthesia maintenance. Geometric mean (95% confidence interval) times to a TOF ratio of ≥ 0.9 were 2.1 (1.7 - 3.1) min (2 mg/kg) and 1.8 (1.5 - 2.7) min (4 mg/kg).

CONCLUSION

Sugammadex 2 mg/kg and 4 mg/kg were well tolerated and effective in patients with a history of pulmonary disease. Bronchospasm is a possibility when administering sugammadex to patients with underlying pulmonary disease.