Woo 2013.

Methods	Study design: randomized, parallel‐group, active‐controlled, safety assessor‐blinded, phase 4 study Sample size calculation: powered to detect whether geometric mean recovery time to TOFR > 0.9 with sugammadex is ≥ 5 times faster than geometric mean time with neostigmine, and whether geometric mean recovery time to TOFR > 0.9 with sugammadex is < 3 minutes
Participants	Number of randomized participants: 128 Inclusion criteria: ASA I to III, either sex, aged > 18 years, of Korean descent, born in Korea, never having emigrated out of Korea and with a Korean home address, scheduled for elective surgery under general anaesthesia Exclusion criteria: any anatomical malformation that might cause difficult intubation; transferred to the ICU after surgery; neuromuscular disorders that could affect the NMB; significant renal or hepatic dysfunction; requirement of a pneumatic tourniquet during surgery; (family) history of malignant hyperthermia; allergy to opioids/opiates, cyclodextrins including sugammadex, muscle relaxants and their excipients, or other medications used during general anaesthesia; administration of toremifene and/or fusidic acid within 24 hours of study drug administration (or plan to administer these drugs within 24 hours after study drug administration); any condition contraindicating neostigmine and/or glycopyrrolate; pregnant females; participation in a previous sugammadex study; participation in another clinical drug study within 30 days inclusive of signing consent for the current study; or a member of, or related to, the investigational staff or sponsor staff
Interventions	Anaesthesia: induced with intravenous propofol and maintained with inhalational sevoflurane. Opioids were administered according to local practice when clinically required NMBA: single intubation dose: rocuronium 0.6 mg/kg; maintenance dose: 0.1 to 0.2 mg/kg rocuronium as clinically required Comparison: sugammadex 2.0 mg/kg (n = 64) vs neostigmine 50 µg/kg plus glycopyrrolate 10 µg/kg (n = 64) Administration time of sugammadex or neostigmine: reappearance of T2
Outcomes	Primary efficacy endpoint: time from start of administration of sugammadex to recovery of TOFR to 0.9 Secondary efficacy endpoints: time to recovery of TOFR to 0.7 and 0.8; time to reappearance of T2 after last dose of rocuronium Safety assessment: adverse events, serious adverse events, vital signs, physical examination findings, clinical evidence of residual NMB and recurrence of NMB
Notes	Publication type: peer‐reviewed article Country: 7 sites in the Republic of Korea Conversions: range to SD following guidelines from Hozo 2005 Handling of adverse events: No discrepancy exists between AEs presented in the original article and those reported in this review Authors' conclusions: Sugammadex was well tolerated and provided rapid reversal of moderate rocuronium‐induced NMB in Korean patients, with recovery time 8.1 times faster than that of neostigmine. These results are consistent with those reported for Caucasian patients Contact: first trial author Tiffany Woo contacted first time by email: tiffany.woo@merck.com on 22.09.2015; has replied * Indicates unpublished data
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Eligible participants were randomized on a 1:1 basis A centralized computer‐generated randomization schedule was used *
Allocation concealment (selection bias)	Low risk	Electronic interactive Web‐based system, so randomization codes were located inside the system and could not be accessed until a participant was registered in the system and 1 code was assigned per participant *
Blinding of participants (performance bias)	Low risk	Participants were considered to be blinded, as they did not participate in the randomization procedure and were under general anaesthesia *
Blinding of personnel (performance bias)	High risk	The anaesthesiologist administering anaesthesia during the surgical procedure was not blinded to the randomized study drug, but was not allowed to reveal the assigned treatment group to the safety assessor
Blinding of primary outcome assessment (detection bias)	High risk	TOF‐watch assessor was not blinded *
Blinding of safety assessment (detection bias)	Low risk	Safety assessors were blinded to the treatment assignment
Incomplete outcome data (attrition bias) All outcomes	Low risk	All participants are accounted for, and missing outcome data are balanced in numbers across intervention groups, with similar reasons for missing data across groups: 128 participants randomized, all‐subjects treated population: 120 (n = 60 in each group), intention to treat population: 118 (n = 59 in each group), per‐protocol population: 116 (n = 59 in the sugammadex group, n = 57 in the neostigmine group). Two participants had major protocol violations (received neostigmine more than 2 minutes after reappearance of T2). All efficacy data for these participants were excluded from the per‐protocol analysis set. Imputed data in both groups were due to loss of calibration of TOF watch during the course of the trial and inability to recalibrate the TOF watch to collect efficacy data *
Selective reporting (reporting bias)	Low risk	Study protocol is available on clinicaltrials.gov (NCT01050543), and all of the study's prespecified primary and secondary outcomes of interest to the review have been reported in the prespecified way
Funding bias	High risk	This study was sponsored by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Whitehouse Station, NJ, USA. Disclosures: Tiffany Woo and Phillip Phiri are employees of Merck Sharp & Dohme Corp., Whitehouse Station, NJ
Other bias	Low risk	Appears free of other sources of bias. Study sample size calculation designed to address this review's primary outcome. Participant demographics well balanced between treatment groups; types of elective surgical procedures performed are comparable