Effects of sugammadex on incidence of postoperative residual neuromuscular blockade: a randomized, controlled study.
BACKGROUND
This study aimed to investigate whether reversal of rocuronium-induced neuromuscular blockade with sugammadex reduced the incidence of residual blockade and facilitated operating room discharge readiness.


METHODS
Adult patients undergoing abdominal surgery received rocuronium, followed by randomized allocation to sugammadex (2 or 4 mg kg(-1)) or usual care (neostigmine/glycopyrrolate, dosing per usual care practice) for reversal of neuromuscular blockade. Timing of reversal agent administration was based on the providers' clinical judgement. Primary endpoint was the presence of residual neuromuscular blockade at PACU admission, defined as a train-of-four (TOF) ratio <0.9, using TOF-Watch® SX. Key secondary endpoint was time between reversal agent administration and operating room discharge-readiness; analysed with analysis of covariance.


RESULTS
Of 154 patients randomized, 150 had a TOF value measured at PACU entry. Zero out of 74 sugammadex patients and 33 out of 76 (43.4%) usual care patients had TOF-Watch SX-assessed residual neuromuscular blockade at PACU admission (odds ratio 0.0, 95% CI [0-0.06], P<0.0001). Of these 33 usual care patients, 2 also had clinical evidence of partial paralysis. Time between reversal agent administration and operating room discharge-readiness was shorter for sugammadex vs usual care (14.7 vs. 18.6 min respectively; P=0.02).


CONCLUSIONS
After abdominal surgery, sugammadex reversal eliminated residual neuromuscular blockade in the PACU, and shortened the time from start of study medication administration to the time the patient was ready for discharge from the operating room.


BACKGROUND
Clinicaltrials.gov:NCT01479764.
Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA02114, USA.
B
B
Brueckmann
Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA02114, USA.
N
N
Sasaki
Biostatistics and Research Decision Sciences, MSD, Oss, The Netherlands.
P
P
Grobara
Clinical Research, Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA.
M K
MK
Li
Clinical Research, Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA.
T
T
Woo
Clinical Research, Merck Sharp & Dohme Corp, Whitehouse Station, NJ, USA.
J
J
de Bie
Trauma, Emergency Surgery, Surgical Critical Care, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
M
M
Maktabi
Trauma, Emergency Surgery, Surgical Critical Care, Massachusetts General Hospital, Harvard Medical School, Boston, MA, USA.
J
J
Lee
Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA02114, USA Harvard Medical School, Boston, MA, USA.
J
J
Kwo
Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA02114, USA Harvard Medical School, Boston, MA, USA.
R
R
Pino
Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA02114, USA.
A S
AS
Sabouri
Harvard Medical School, Boston, MA, USA Department of Urology, Massachusetts General Hospital, 55 Fruit Street, Boston, MA 02114, USA.
F
F
McGovern
Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA02114, USA Department of Anesthesiology, Herlev Hospital, University of Copenhagen, Herlev, Denmark.
A K
AK
Staehr-Rye
Department of Anesthesia, Critical Care, and Pain Medicine, Massachusetts General Hospital, 55 Fruit Street, Boston, MA02114, USA Harvard Medical School, Boston, MA, USA Essen-Duisburg University, Essen, Germany meikermann@partners.org.
M
M
Eikermann
D000005:Abdomen / Q000601:surgery; D000328:Adult; D000368:Aged; D000732:Androstanols / Q000037:antagonists & inhibitors*; D000762:Anesthesia Recovery Period; D000768:Anesthesia, General / Q000379:methods; D055191:Delayed Emergence from Anesthesia / Q000517:prevention & control*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004338:Drug Combinations; D005260:Female; D006024:Glycopyrrolate / Q000494:pharmacology; D006801:Humans; D008297:Male; D008875:Middle Aged; D009388:Neostigmine / Q000494:pharmacology; D019148:Neuromuscular Blockade; D009469:Neuromuscular Junction / Q000187:drug effects* / Q000503:physiopathology; D003473:Neuromuscular Nondepolarizing Agents / Q000037:antagonists & inhibitors*; D011182:Postoperative Care / Q000379:methods; D000077123:Rocuronium; D000077122:Sugammadex; D047408:gamma-Cyclodextrins / Q000008:administration & dosage / Q000009:adverse effects / Q000494:pharmacology*
D000732:Androstanols; D004338:Drug Combinations; D003473:Neuromuscular Nondepolarizing Agents; D047408:gamma-Cyclodextrins; D000077122:Sugammadex; D009388:Neostigmine; D006024:Glycopyrrolate; D000077123:Rocuronium
neostigmine/glycopyrrolate; neuromuscular blockade; neuromuscular blocking agents; randomized-controlled trial; rocuronium; sugammadex