NCT02414880.

Trial name or title	Sugammadex versus neostigmine in patients with liver cirrhosis undergoing liver resection
Methods	Allocation: randomized Endpoint classification: pharmacodynamics study Intervention model: parallel assignment Masking: open‐label Primary purpose: treatment
Participants	Estimated enrolment: 60 Inclusion criteria: ASA class I for patients with preoperative normal liver function test (2 groups) and I to III for those with liver cirrhosis (2 groups). For the 2 "Liver cirrhosis" groups: patients with liver cirrhosis with Child classification "A" and a Model for End‐Stage Liver Disease (MELD) score < 10 undergoing liver resection surgery For the 2 "Normal liver" groups: patients with normal preoperative liver function undergoing liver resection surgery Exclusion criteria: Coexisting neuromuscular disease BMI > 35 kg/m2 Renal impairment Medications known to affect neuromuscular transmission (e.g. aminoglycoside antibiotics, magnesium sulphate) Bleeding tendency Intraoperative adverse events (e.g. massive bleeding, hypothermia)
Interventions	Sugammadex 2 mg/kg ‐ normal liver Neostigmine 50 micrograms/kg combined with atropine 20 micrograms/kg ‐ normal liver Sugammadex 2 mg/kg ‐ liver cirrhosis Neostigmine 50 micro‐grams/kg combined with atropine 20 micro‐grams/kg ‐ liver cirrhosis
Outcomes	Primary outcome measures: Time from reversal to TOFR = 0.9 [Time Frame: 15 minutes] [Designated as safety issue: no] Time from administration of sugammadex or neostigmine to recovery of TOFR to 0.9 Secondary outcome measures: Time from reversal to TOFR = 1 [Time Frame: 30 minutes] [Designated as safety issue: no] Time from administration of sugammadex or neostigmine until recovery of TOFR = 1 Length of stay in the post‐anaesthesia care unit (PACU) [Time Frame: 4 hours] [Designated as safety issue: no] Time required in post‐anaesthesia care unit (PACU) to achieve a modified Aldrete score of 9 Time from last rocuronium dose to TOFR = 0.9 [Time Frame: 1 hour] [Designated as safety issue: no] Time from last dose of rocuronium to recovery of TOFR = 0.9 Duration of action of initial intubating dose of rocuronium [Time Frame: 45 minutes] [Designated as safety issue: no] Time interval between initial rocuronium intubating dose administration and recovery of first twitch of TOF response (T1) Incidence of postoperative recurarization [Time Frame: 4 hours] [Designated as safety issue: yes] Recurrence of neuromuscular block (recurarization) will be defined as a decrease in TOFR to < 0.9 after full recovery had been detected, or as deterioration in clinical signs of recovery from the block Total dose of rocuronium [Time Frame: 24 hours] [Designated as safety issue: no] Total dose of rocuronium used during the whole operation including intubating dose and subsequent top‐ups Duration of anaesthesia [Time Frame: 24 hours] [Designated as safety issue: no] Duration between induction of anaesthesia and complete recovery of consciousness and motor power
Starting date	December 2014
Contact information	Mohamed Abdulatif Mohamed, MD, Cairo University
Notes	This study has been completed. No study results have been published yet to the best of our knowledge