Ojima 2017.
Methods | RCT, parallel design | |
Participants |
Total number of randomized participants: 100 Inclusion criteria: pathologically confirmed thoracic oesophageal carcinoma; planned right transthoracic oesophagectomy with 2‐ or 3‐field lymph node dissection; clinical stage I, II, III or IV according to the UICC TNM classification; Eastern Cooperative Oncology Group performance status 0‐1; 20‐85 years of age; normal major organ function Exclusion criteria: resting HR < 50 bpm, 2nd‐ or 3rd‐degree atrioventricular block; history of AF. In addition, at randomization, participants were excluded if they were receiving dopamine, SBP < 80 mmHg or > 160 mmHg, HR < 50 bpm, or with arrhythmias or requiring ventilator assistance Type of surgery: oesophagectomy Baseline characteristics Intervention group (landiolol)
Control group (placebo)
Country: Japan Setting: hospital; single centre |
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Interventions |
Intervention group (landiolol)
Control group (placebo)
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Outcomes |
Outcomes measured/reported by study authors: AF (between days 1‐7); rate of occurrence of AF in hospital; postoperative complications; haemodynamic parameters; change in inflammatory markers; mobility scores; side effects (to include hypotension and bradycardia); mortality Outcomes relevant to the review: AF, hypotension, bradycardia; mortality |
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Notes |
Funding/declarations of interest: funding not reported. Study authors declare no conflicts of interest Study dates: March 2013‐January 2016 Notes:
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomization at a central registry |
Allocation concealment (selection bias) | Low risk | Organized at a central registry |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "Patients, care providers and investigators were blinded to the treatments." Quote: "The appearance and labelling of the dosage were indistinguishable between landiolol and placebo" |
Blinding of outcome assessors (detection bias) All outcomes | Low risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses |
Selective reporting (reporting bias) | Low risk | Prospective clinical trial registration (UMIN000010648). Outcomes are reported according to clinical trial documents |
Other bias | High risk | Participants in either group who had AF were treated with landiolol |