Schaller 2010.

Methods	Study design: single‐centre, randomized, parallel‐group, double‐blinded study (SUNDRO) Sample size calculation: no information available
Participants	Number of randomized participants: 99 Inclusion criteria: informed written consent, age 18 to 65 years, ASA I to III, scheduled for elective surgery under general anaesthesia with rocuronium for tracheal intubation Exclusion criteria: expected to have a difficult airway; known neuromuscular disease; significant hepatic or renal dysfunction; family history of malignant hyperthermia; known allergy to 1 of the drugs used in this protocol; intake of any medication that might interact with muscle relaxants; pregnant or breastfeeding; participated in another clinical study in the past 30 days
Interventions	Anaesthesia: induced with propofol (2 to 3 mg/kg) and fentanyl (0.1 to 0.2 µg/kg), maintained with propofol and remifentanil according to clinical need and anaesthesiologist preference NMBA: single intubating dose: rocuronium 0.6 mg/kg; maintenance dose: rocuronium 0.1 to 0.2 mg/kg Comparison: sugammadex 0.0625 mg/kg (n = 9), 0.125 mg/kg (n = 9), 0.25 mg/kg (n = 9), 0.5 mg/kg (n = 9), or 1.0 mg/kg (n = 9); or neostigmine 5 µg/kg (n = 9), 8 µg/kg (n = 9), 15 µg/kg (n = 9), 25 µg/kg (n = 9), or 40 µg/kg (n = 9) in a mixture with 1 µg glycopyrrolate/5 µg neostigmine or saline (n = 9) Administration time of sugammadex, neostigmine, or placebo: TOFR = 0.5
Outcomes	Primary endpoint: dose of sugammadex or neostigmine to accelerate time between start of administration of the respective study drug at a TOFR of 0.5 to a TOFR ≥ 0.9 in an average of 2 minutes, with an upper limit of 5 minutes for 95% of participants Secondary endpoints: doses of sugammadex and neostigmine for slower acceleration of reversal (i.e. average time of 5 minutes with upper limit of 10 minutes for 95% of participants) Safety assessment: adverse events and severe adverse events
Notes	Publication type: peer‐reviewed article Country: Germany Conversions: none Handling of adverse events: More detailed information regarding number of adverse events possibly, probably, or definitely related to study drug was provided by trial authors through email correspondence; we used these updated numbers in the review Authors’ conclusions: Sugammadex 0.22 mg/kg can reverse a TOFR of 0.5 to 0.9 or higher in an average time of 2 minutes. Within 5 minutes, 95% of patients reach this TOFR. Neostigmine 34 µg/kg can reverse a TOFR of 0.5 Contact: corresponding trial author Manferd Blobner contacted by email: blobner@lrz.tu‐muenchen.de on 15.03.2016; no reply received
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	"Computer‐generated randomization list"
Allocation concealment (selection bias)	Unclear risk	Unable to assess owing to insufficient information
Blinding of participants (performance bias)	Low risk	Participants were blinded
Blinding of personnel (performance bias)	Low risk	In the operating room, an additional anaesthesiologist prepared study drug according to participant number on the randomization list in an unlabelled syringe. Upon request of the blinded anaesthesiologist responsible for the participant, study drug was injected
Blinding of primary outcome assessment (detection bias)	Low risk	Outcome assessor was blinded
Blinding of safety assessment (detection bias)	Low risk	Safety assessor was blinded
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	All participants are accounted for, but missing outcome data are not balanced in numbers across intervention groups, and it remains unclear whether missing outcome data are due to attrition or exclusion: Study drug was injected in 99 participants. In 5 participants, major protocol violations occurred: in 1 participant, neostigmine was incompletely injected as a result of a leaking venous cannula; and in 4 participants, electromyographic response was unstable (1 each in 5, 8, and 40 µg/kg neostigmine groups; 2 in 0.125 mg/kg sugammadex group). Because these violations might have affected primary and secondary endpoints, respective participant data were omitted, resulting in a per‐protocol population of 94 participants
Selective reporting (reporting bias)	Low risk	Study protocol is available on clinicaltrials.gov (NCT00895609) and EudraCT (2008‐008239‐27); all of the study’s prespecified outcomes of interest to the review have been reported in the prespecified way
Funding bias	High risk	Support was provided solely from institutional and/or departmental sources. Drs. Blobner and Fink have received honoraria and travel grants from Schering‐Plough, Inc. (Kenilworth, New Jersey), although this work was not sponsored by Schering‐Plough in any way
Other bias	Unclear risk	No apparent other type of bias, except no information on sample size calculation. Groups did not differ significantly regarding sex, age, weight, height, and ASA physical status