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. 2019 Sep 26;2019(9):CD013438. doi: 10.1002/14651858.CD013438

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)
  • Age, mean (SD): 67.4 (± 8.7) years

  • Gender, M/F: 14/11


Control group (placebo)
  • Age, mean (SD): 66.9 (± 8.9) years

  • Gender, M/F: 17/8


Country: Japan
Setting: single‐centre; hospital
Interventions Intervention group (landiolol hydrochloride)
  • Randomized, n = 25; losses = 0; analysed, n = 25 (used ITT analysis)

  • Details: given during induction of GA, rate of 5 µg/kg/min, IV, continued until end of anaesthesia


Control group (placebo)
  • Randomized, n = 25; losses = 0; analysed, n = 25

  • Details: placebo, normal saline, given same as the intervention group

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
Notes Funding/declarations of interest: not reported. Study authors declare that they have no conflicts of interest
Study dates: September 2009‐November 2010
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