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. 2019 Sep 23;2019(9):CD013435. doi: 10.1002/14651858.CD013435

Matsuura 2001.

Methods Quasi‐randomized trial, parallel design
Participants Total number of randomized participants: 80
Inclusion criteria: scheduled for CABG surgery
Exclusion criteria: history of AF or atrial flutter, contraindications to beta‐blockers (such as asthma; or concomitant valvular, anti‐arrhythmic, or aortic surgery), severe bradycardia, hypotension
Type of surgery: elective CABG
Baseline characteristics
Intervention group (sotalol)
  • Age, mean (SD): 62 (± 10) years

  • Gender, M/F: 32/8

  • History of hypertension, %: 55

  • Ejection fraction, mean (SD), %: 56 (± 15)

  • Preoperative use of beta‐blockers, %: 50


Control group (standard care)
  • Age, mean (SD): 60 (± 9)

  • Gender, M/F: 33/7

  • History of hypertension, %: 50

  • Ejection fraction, mean (SD), %: 55 (± 14)

  • Preoperative use of beta‐blockers, %: 40


Country: Japan
Setting: single centre; hospital
Interventions Intervention group (sotalol)
  • Randomized, n = 40; losses = 0; analysed, n = 40

  • Details: 80 mg/day, started on the 1st postoperative day and was continued for 2 weeks


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

  • Details: standard care

Outcomes Outcomes measured/reported by study authors: haemodynamic variables, plasma creatinine concentrations, AF, length of stay, mortality, adverse events relating to discontinuation of intervention drug (to include bradycardia and hypotension)
Outcomes relevant to the review: AF; length of stay; mortality; bradycardia and hypotension (see notes below)
Notes Funding/declarations of interest: not reported
Study dates: February 1999‐December 2000
Note:
  • we did not include outcome data for bradycardia and hypotension because we were uncertain whether events were measured in the control group. Study authors reported discontinuation of sotalol due to bradycardia in 2 participants, and due to hypotension (and other conditions) in 1 participant

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) High risk Quote: "Patients were randomised alternately"
Comment: quasi‐randomization
Allocation concealment (selection bias) High risk See above
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Open‐label trial
Blinding of outcome assessors (detection bias) 
 All outcomes High risk Open‐label trial
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No apparent losses
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