Janssen 1986.
Methods | RCT, parallel design | |
Participants |
Total number of randomized participants: 151 Inclusion criteria: scheduled for CABG surgery, with left ventricular ejection fraction at least 30% Exclusion criteria: preoperative MI, inotropic support with dopamine, postoperative death, severe sinus bradycardia, inappropriate data (no additional details) Type of surgery: elective CABG Baseline characteristics Intervention group (sotalol)
Intervention group (metoprolol)
Control group (standard care)
Country: Netherlands Setting: single centre; hospital |
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Interventions |
Intervention group (sotalol)
Intervention group (metoprolol)
Control group (standard care)
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Outcomes |
Outcomes measured/reported by study authors: supraventricular tachycardias, atrial fibrillation Outcomes relevant to the review: AF, mortality |
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Notes |
Funding/declarations of interest: not reported Study dates: October 1983‐January 1984
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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 | Use of sealed envelopes; no additional details |
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 | High risk | 21 participants excluded from analysis (2 MI, 12 inotropic support after CABG, 1 death, 1 bradycardia, 5 inappropriate data). It is not clear to which group these participants belonged |
Selective reporting (reporting bias) | High risk | We noted that study authors appeared to only report statistically significant results |
Other bias | High risk | All participants were given beta‐blockers, if required, to treat supraventricular tachycardia. In the control group, 10 participants were given sotalol, and 4 participants were given metoprolol. This may influence outcome data for mortality |