Skip to main content
. 2019 Sep 23;2019(9):CD013435. doi: 10.1002/14651858.CD013435

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)
  • Age, mean (range): 58 (31‐74) years

  • Gender, M/F: 34/7

  • History of MI, n: 11


Intervention group (metoprolol)
  • Age, mean (range): 57.5 (37‐68) years

  • Gender, M/F: 31/8

  • History of MI, n: 16


Control group (standard care)
  • Age, mean (range): 59.6 (39‐72) years

  • Gender, M/F: 40/10

  • History of MI, n: 19


Country: Netherlands
Setting: single centre; hospital
Interventions Intervention group (sotalol)
  • Randomized, n = unclear; losses = unclear; analysed, n = 41 (ITT analysis not used)

  • Details: 1 h after surgery 0.3 mg/kg sotalol, IV. At 24 h postoperatively, 3 X 80 mg sotalol orally, daily, until hospital discharge


Intervention group (metoprolol)
  • Randomized, n = unclear; losses = unclear; analysed, n = 39

  • Details: 1 h after surgery 0.1 mg/kg metoprolol, IV. At 24 h postoperatively, 3 X 50 mg metoprolol orally, daily, until hospital discharge


Control group (standard care)
  • Randomized, n = unclear; losses = unclear; analysed, n = 50

  • Details: received no prophylactic therapy

Outcomes Outcomes measured/reported by study authors: supraventricular tachycardias, atrial fibrillation
Outcomes relevant to the review: AF, mortality
Notes Funding/declarations of interest: not reported
Study dates: October 1983‐January 1984
  • we could not be certain of the number of participants randomized to each group

  • we combined data for the sotalol and the metoprolol groups

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