Kizilay 2016.
Methods |
Study design: prospective, randomized study Sample size calculation: no information available |
|
Participants |
Number of randomized participants: 90 Inclusion criteria: aged 18 to 75 with grade 2 or 3 cardiovascular disease according to New York Heart Association classification undergoing non‐cardiac surgery; free of any clinical infection; chronic alcohol use or substance abuse history; free of contraindications to atropine, neostigmine, or sugammadex Exclusion criteria: did not give written consent;respiratory or cardiac arrest, cerebral bleeding, ischaemia, infarct, or hypersensitivity reaction to any of the study medications |
|
Interventions |
Anaesthesia: induction with 5 mg/kg IV thiopental sodium; maintenance: sevoflurane, 70% N2O and 30% O2 to MAC 1 NMBA: single intubating dose: rocuronium 0.8 mg/kg; maintenance dose: no information available Comparison: sugammadex 3 mg/kg (n = 45) vs neostigmine 30 µg/kg (n = 45) Administration time of sugammadex or neostigmine: reappearance of T2 |
|
Outcomes | Heart rate, mean systolic and diastolic blood pressures, and electrocardiographic alterations including QTc (QT Fredericia and QT Bazett) were recorded | |
Notes |
Publication type: peer‐reviewed article Country: Turkey Conversions: none Handling of adverse events: No discrepancy exists between AEs presented in the original article and those reported in this review Authors’ conclusions: We suggest that sugammadex might be preferred, as it provides greater haemodynamics stability than is provided by the neostigmine‐atropine combination to reverse rocuronium‐induced neuromuscular blockade in cardiac patients undergoing non‐cardiac surgery Contact: first trial author Deniz Kizilay contacted by email: denizkizilay@yahoo.com on 24.05.2016; replied 29.05 * Indicates unpublished data |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization by lots * |
Allocation concealment (selection bias) | High risk | No allocation concealment * |
Blinding of participants (performance bias) | Low risk | Participants were blinded * |
Blinding of personnel (performance bias) | High risk | Personnel were not blinded * |
Blinding of primary outcome assessment (detection bias) | High risk | TOF‐watch assessor was not blinded * |
Blinding of safety assessment (detection bias) | High risk | Safety assessor was not blinded * |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐outs: 90 participants were randomized, 45 to each group |
Selective reporting (reporting bias) | Low risk | Study protocol not available, but published article clearly includes all expected outcomes |
Funding bias | Low risk | Study was funded by the first trial author * |
Other bias | Unclear risk | No apparent other type of bias, except no information on sample size calculation. No significant differences between groups in terms of age, sex, weight, ASA‐, NYHA‐ classification, or comorbid disorders, except coronary disease |