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

Suttorp 1991.

Methods RCT, parallel design
Participants Total number of randomized participants: 303
Inclusion criteria: people who had undergone CABG surgery without concomitant procedures (valve replacement, ventricular aneurysmectomy or others), in sinus rhythm
Exclusion criteria: people with left ventricular ejection fraction < 40% or postoperative resting ventricular rate < 50 bpm; history of obstructive lung disease, recurrent or persistent ST during 1st 4 h after surgery, conduction disturbances, ventricular tachycardia or fibrillation immediately after surgery, postoperative intra‐aortic balloon pumping, inotropic support for ≥ 6 h, renal failure, potassium ion concentration not between 3.5 and 5.3 mmol/L, or contraindications to beta‐blockers
Type of surgery: elective CABG
Baseline characteristics
Intervention group (sotalol)
  • Age, mean (SD): 62 (± 8.4) years

  • Gender, M/F: 121/29

  • NYHA, mean (SD): 2.9 (± 0.7)

  • History of MI, n: 75

  • Preoperative use of beta‐blockers, n: 118


Control group (placebo)
  • Age, mean (SD): 62 (± 9.5) years

  • Gender, M/F: 113/37

  • NYHA, mean (SD): 2.9 (± 0.8)

  • History of MI, n: 77

  • Preoperative use of beta‐blockers, n: 108


Country: Netherlands
Setting: single centre; hospital
Interventions Intervention group (sotalol)
  • Randomized, n = unclear; losses = unclear (loss of 3 participants but study authors do not report to which group these participants belonged); analysed, n = 150 (ITT analysis not used)

  • Details: sotalol 40 mg every 6 h, started within 4‐6 h after surgery, and continued for 6 days


Control group (placebo)
  • Randomized, n = unclear; losses = unclear (loss of 3 participants but study authors do not report to which group these participants belonged); analysed, n = 150 (ITT analysis not used)

  • Details: placebo dose every 6 h same as the intervention group

Outcomes Outcomes measured/reported by study authors: supraventricular tachyarrhythmias (to include AF, atrial tachycardia, SVT), mortality, MI (perioperative); adverse events requiring discontinuation of study medication (to include hypotension with bradycardia)
Outcomes relevant to the review: AF, mortality, MI (perioperative); adverse events (to include hypotension with bradycardia)
Notes Funding/declarations of interest: not reported
Study dates: September 1989‐February 1990
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 Low risk Randomized, double‐blind, placebo‐controlled trial
Blinding of outcome assessors (detection bias) 
 All outcomes Unclear risk Not specified
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 3 participants were excluded from analysis because of protocol violations (per‐protocol analysis); 303 participants enrolled. Few losses (< 10%)
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 Unclear risk Quote: "In patients with persistent sinus tachycardia, trial medication was stopped and treatment with a beta‐blocking agent was begun".
Comment: it is unclear from the study results whether any participants had persistent sinus tachycardia