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)
Control group (placebo)
Country: Netherlands Setting: single centre; hospital |
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Interventions |
Intervention group (sotalol)
Control group (placebo)
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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) |
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Notes |
Funding/declarations of interest: not reported Study dates: September 1989‐February 1990 |
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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 |