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

Babin‐Ebell 1996.

Methods RCT, parallel design
Participants Total number of randomized participants: 70
Inclusion criteria: scheduled for CABG
Exclusion criteria: unstable angina, bradycardia (HR < 50 bpm), COPD, ejection fraction < 0.4, history of SVT and additional surgical procedures
Type of surgery: elective CABG
Baseline characteristics
Intervention group (propranolol)
  • Age, mean (SD): 61.4 (± 8.7) years

  • Gender, M/F: 25/8

  • NYHA class II/III, n: 13/20

  • History of myocardial infarction, %: 57

  • History of hypertension, %: 66

  • Preoperative use of beta‐blockers, %: 61


Control group (standard care)
  • Age, mean (SD): 64.3 (± 9.1) years

  • Gender, M/F: 31/6

  • NYHA class II/III, n: 10/27

  • History of myocardial infarction, %: 35

  • History of hypertension, %: 49

  • Preoperative use of beta‐blockers, %: 65


Country: Germany
Setting: hospital; single centre
Interventions Intervention group (propranolol)
  • Randomized, n = 33; losses = 8 (withdrawal owing to: hypotension 5; bradycardia 1; perioperative MI 1, SVT 2); analysed, n = 33 (ITT analysis not used by study authors; we re‐included data where possible), n = 27 for supraventricular arrhythmias

  • Details: 10 mg propranolol every 6 h postoperatively, up to 72 h


Control group (standard care)
  • Randomized, n = 37; losses = 14 (withdrawal owing to: MI 1; SVT 13); analysed, n = 37

  • Details: no anti‐arrhythmic agents were administered, up to 72 h

Outcomes Outcomes measured/reported by study authors: supraventricular tachycardia, haemodynamic parameters, cardiac enzyme levels, use of catacholamines (to manage low cardiac output, or hypotension) and leading to withdrawal from treatment, MI, bradycardia. Outcomes were assessed up to 7 days following surgery
Outcomes relevant to the review: acute MI, bradycardia
Notes Funding/declarations of interest: not reported
Study dates: not reported
Note:
  • study includes a 3rd arm (diltiazem), which we did not include in the review

  • study authors reported data for supraventricular tachycardia at 2 time points. At the final time point (7 days), 1 participant in the control group developed supraventricular tachycardia; we did not include this in analysis of the earlier time point because we could not be certain whether this introduced a unit of analysis error

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 6 participants were excluded from analysis of supraventricular arrhythmias ‐ we re‐included these lost participants for data for bradycardia, hypotension, MI). Losses are 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 Low risk Not detected