Aoyama 2016.
Methods | RCT, parallel design | |
Participants |
Total number of randomized participants: 50 Inclusion criteria: adults of either gender; 20‐90 years of age; ASA I or II; scheduled to undergo elective segmentectomy, lobectomy, or pneumonectomy of the lung under GA with thoracic epidural anaesthesia Exclusion criteria: participant refusal; inability to communicate in Japanese; contraindications to epidural anaesthesia; recent history or evidence of acute MI; and supraventricular arrhythmia (under treatment or requiring treatment); 2nd‐ or 3rd‐degree atrioventricular block; severe heart failure; left ventricular ejection fraction ≤ 35%; prohibition from beta‐blocker; hypotension (≤ 90/60 mmHg); bradycardia (≤ 50 bpm) Type of surgery: elective segmentectomy, lobectomy, or pneumonectomy of the lung Baseline characteristics Intervention group (landiolol hydrochloride)
Control group (placebo)
Country: Japan Setting: single‐centre; hospital |
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Interventions |
Intervention group (landiolol hydrochloride)
Control group (placebo)
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Outcomes |
Outcomes measured/reported by study authors: AF (in 7 days postoperatively); predictive bio‐markers of AF (serum magnesium, IL6 etc.); adverse events (not specified); mortality (time point not specified) Outcomes relevant to the review: AF; mortality |
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Notes |
Funding/declarations of interest: not reported. Study authors declare that they have no conflicts of interest Study dates: September 2009‐November 2010 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Use of computer‐generated randomization table |
Allocation concealment (selection bias) | Low risk | Use of sealed, non‐transparent envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Described as double‐blinded, placebo controlled. We have assumed that participants were blinded |
Blinding of outcome assessors (detection bias) All outcomes | Unclear risk | No details |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses reported. Study authors planned to use ITT analysis |
Selective reporting (reporting bias) | Unclear risk | Study authors did not report prospective clinical trial registration or publication of a protocol. It was not feasible to effectively assess risk of reporting bias |
Other bias | Low risk | Not detected |