Cheong 2015.
Methods |
Study design: randomized, controlled study Sample size calculation: calculated under the presumption that the difference in time to 90% recovery of TOFR between groups was not longer than 30 seconds |
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Participants |
Number of randomized participants: 120 Inclusion criteria: age between 18 and 65 years, ASA I to II, scheduled for elective surgery Exclusion criteria: expected to have difficult intubation owing to anatomical abnormality or limited neck mobility at preoperative evaluation; neuromuscular abnormality; cardiovascular disease; kidney function disorder; liver function disorder; pregnancy; and history of side effects with aesthetics and analgesics. Experiment withdrawal criteria were unexpected massive haemorrhage; unrecovered electrocardiograph (ECG) abnormality; profound hypotension; respiratory abnormality; and TOF device error during experiment |
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Interventions |
Anaesthesia: induced with propofol 1.5 to 2.5 mg/kg and maintained with sevoflurane 1.5 to 2.5 vol % and 50% N2O. NMBA: single intubating dose: rocuronium 0.6 mg/kg; maintenance dose: rocuronium 5 to 10 mg Comparison: sugammadex 2 mg/kg (S2) (n = 30), sugammadex 1 mg/kg (S1) (n = 30), sugammadex 1 mg/kg + neostigmine 0.05 mg/kg + glycopyrrolate 0.01 mg/kg (SN) (n = 30), and neostigmine 0.05 mg/kg + glycopyrrolate 0.01 mg/kg (N) (n = 30) Administration time of sugammadex, sugammadex + neostigmine, or neostigmine: reappearance of T1 to 2 |
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Outcomes | Time to 90% recovery of TOFR, adverse events: PONV score, signs of residual blockade, BP, oxygen saturation | |
Notes |
Publication type: peer‐reviewed article Country: Korea Conversions: sugammadex time Mean + SD from seconds to minutes Handling of adverse events: No discrepancy exists between AEs presented in the original article and those reported in this review Authors’ conclusions: For reversal from rocuronium‐induced moderate neuromuscular blockade, combined use of sugammadex and neostigmine may be helpful to decrease recovery time and can reduce the required dosage of sugammadex. However, the increased incidence of systemic muscarinic side effects must be considered Contact: first trial author Wonjin Lee contacted by email: 2wonjin@hanmail.net on 15.05.2016; no reply received |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Subjects randomly assigned"; no further information available |
Allocation concealment (selection bias) | Unclear risk | Unable to assess owing to insufficient information |
Blinding of participants (performance bias) | Unclear risk | Unable to assess owing to insufficient information |
Blinding of personnel (performance bias) | Low risk | To minimize observer bias, drugs were prepared in syringes labelled "reverse" by a third party |
Blinding of primary outcome assessment (detection bias) | Unclear risk | Unable to assess owing to insufficient information |
Blinding of safety assessment (detection bias) | Unclear risk | Unable to assess owing to insufficient information |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐outs: 120 participants were enrolled and randomized, resulting in 4 groups of 30 participants |
Selective reporting (reporting bias) | Low risk | Study protocol not available, but published article clearly includes all expected outcomes |
Funding bias | Low risk | This work was supported by the 2011 Inje University research grant |
Other bias | High risk | Appears free of other sources of bias. Study sample size calculation designed to address this review's primary outcome. Baseline characteristics showed significant differences (P = 0.035) between body weight in 2 groups, which influences the dosage of administered drug and therefore can influence time to recovery of TOFR, MBP, HR, and PONV score |