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

Jacquet 1994.

Methods RCT, parallel design
Participants Total number of randomized participants: 42
Inclusion criteria: scheduled for CABG surgery without a concomitant procedure, in sinus rhythm, preoperative left ventricular ejection fraction of > 35%, no contraindication to use of beta‐blockers, HR > 50 bpm, SBP > 100 mmHg, cardiac index > 2.8 L/min/m², pulmonary capillary wedge pressure < 15 mmHg without inotropic support
Exclusion criteria: history of recurrent SVA, atrioventricular conduction disturbances, prolonged QT interval, chronic obstructive airway diseases treated with aerosolized beta‐sympathomimetic drugs, significant renal or hepatic dysfunction
Type of surgery: elective CABG
Baseline characteristics
Intervention group (sotalol)
  • Age, mean (SD): 59.3 (± 9.2) years

  • Gender, M/F: 21/4

  • History of MI, n: 9

  • Ejection fraction, mean (SD), %: 56 (± 11.5)

  • Preoperative use of beta‐blockers, n: 16


Control group (standard care)
  • Age, mean (SD): 61.7 (± 6) years

  • Gender, M/F: 16/1

  • History of MI, n: 9

  • Ejection fraction, mean (SD), %: 60.3 (± 13.7)

  • Preoperative use of beta‐blockers, n: 9


Country: Belgium
Setting: single centre; hospital
Interventions Intervention group (sotalol)
  • Randomized, n = 25; losses = 6 (for bradycardia and hypotension); analysed, n = 25 (data available for bradycardia, hypotension, and length of stay), n = 19 (data for arrhythmias) (ITT analysis not used, but we were able to re‐include data for relevant outcomes)

  • Details: 6 h postoperatively in the ICU, loading infusion of 1 mg/kg sotalol over 2 h, followed maintenance dose IV 0.15 mg/kg/h for 24 h. Then 80 mg orally every 12 h or 8 h according to HR and overall condition for following 3 months


Control group (standard care)
  • Randomized, n = 17; losses = 0; analysed, n = 17

  • Details: no anti‐arrhythmic treatment

Outcomes Outcomes measured/reported by study authors: haemodynamic parameters, supraventricular arrhythmias, length of hospital stay, perioperative MI, discontinuation of intervention due to hypotension (SBP < 90 mmHg) and bradycardia (HR < 50 bpm)
Outcomes relevant to the review: length of hospital stay, perioperative MI, hypotension (see notes below), bradycardia (see notes below)
Notes Funding/declarations of interest: not reported
Study dates: not reported
Note:
  • we did not include data for bradycardia and hypotension in analysis, because we could not be certain whether any events occurred in the control group. In the intervention group, 3 participants had bradycardia, and 3 had hypotension

  • Early stopping: "Because of the large number of drop‐outs with this treatment it was decided to end the study after 6 months even though there was a trend towards better results with sotalol than without"

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 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 Withdrawal of treatment in 6 participants in the treatment group (because of bradycardia and hypotension). Analysis of arrhythmias did not included these participants. Loss is < 10%, but is imbalanced between groups
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 We noted more participants in the intervention group were taking beta‐blockers preoperatively