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

Yoshida 2017.

Methods RCT, parallel design
Participants Total number of randomized participants: 80
Inclusion criteria: ≥ 20 years of age; pathologically confirmed oesophageal cancer not previously treated by surgery
Exclusion criteria: cardiac shock; metabolic acidosis; diabetic mellitus‐related ketoacidosis; 2nd‐degree atrioventricular block; pulmonary hypertension‐related right heart failure; congestive heart failure; untreated phaeochromocytoma; hypersensitivity to components of landiolol hydrochloride
Type of surgery: transthoracic oesophagectomy
Baseline characteristics
Intervention group (landiolol)
  • Age, median (range): 64 (48‐79) years

  • Gender, M/F: 35/4

  • History of hypertension, %: 30.8

  • History of ischaemic heart disease, %: 2.6


Control group (placebo)
  • Age, median (range): 62 (45‐82) years

  • Gender, M/F: 32/8

  • History of hypertension, %: 27.5

  • History of ischaemic heart disease, %: 2.5


Country: Japan
Setting: single centre; hospital
Interventions Intervention group (landiolol)
  • Randomized, n = 40; losses = 1 (due to preoperative AF); analysed, n = 39 (use of ITT analysis not reported)

  • Details: landiolol hydrochloride 5 µg/kg/min, IV infusion, started during surgery and continued for 24 h


Control group (placebo)
  • Randomized, n = 40; losses = 0; analysed, n = 40

  • Details: normal saline, same as the intervention group

Outcomes Outcomes measured/reported by study authors: AF, tachycardia (not defined as ventricular or supraventricular); postoperative complications; adverse events ‐ hypotension (SBP < 80 mmHg) or bradycardia (< 50 bpm)
Outcomes relevant to the review: AF; bradycardia and hypotension (see notes below)
Notes Funding/declarations of interest: not reported
Study dates: July 2009‐March 2014
Notes:
  • epidural anaesthesia combined with GA was given in 36 participants in the control group, and 33 participants in the intervention group

  • we did not include data for hypotension and bradycardia in analysis because study authors only reported these data for the intervention group ‐ "No adverse events, such as hypotension (<systolic blood pressure 80 mmHg) or bradycardia (< 50 bpm), requiring interruption of intravenous landiolol infusion were identified in this study"

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specified
Allocation concealment (selection bias) Unclear risk Not specified
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Placebo‐controlled trial. However, it is not clear whether anaesthetists were blinded to treatment
Blinding of outcome assessors (detection bias) 
 All outcomes Unclear risk Not specified
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Loss of 1 participant in the intervention group
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