[Clinical evaluation of post-surgical bleeding after a sugammadex injection]

Abstract

Objective: Sugammadex reverses neuromuscular blockade by chemical encapsulation of nondepolarizing neuromuscular blocking drugs (rocuronium and vecuronium). The imprint of this new molecule has recently been supplemented with a section on haemostasis notifying a longer clotting time without documented clinical consequences. This has resulted in recommendations on the use of sugammadex in the presence of coagulation disorders (pharmacologically-induced or not). The objective of this study was to analyze the experience gathered with this molecule on clinically-evaluated bleeding. No study on this subject is currently available.

Methods: This is a retrospective study over 1 year between August 2009 and August 2010. All patients with laparotomies for cancer surgery requiring suction drains were included. Patients were allocated to groups according to the type of reversal (without sugammadex versus sugammadex 2 or 4 mg/kg). The endpoint was clinically-evaluated postoperative bleeding (reoperation for haemostasis, blood-stained laparotomy dressings in the post-anaesthesia care unit [PACU], cumulative volume collected in suction drains upon arrival in PACU and then after 2 hours and the next morning at 6a.m).

Results: One hundred and ninety-three patients were included in three groups, 78 in the group "without sugammadex", 95 in "sugammadex 2mg/kg" and 20 in "sugammadex 4 mg/kg". There were no reoperations for haemostasis. The comparison among different groups for the endpoint of bleeding showed no significant difference.

Conclusion: In this retrospective study performed in patients at high risk of postoperative bleeding, sugammadex at doses of 2 and 4 mg/kg was not associated with increased bleeding. This study, the first in this field, suggests that future prospective investigations should target patients receiving 4 or 16 mg/kg of sugammadex and/or with documented preoperative abnormal coagulations tests.