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. 2019 Sep 26;2019(9):CD013438. doi: 10.1002/14651858.CD013438

Bayliff 1999.

Methods RCT, parallel design
Participants Total number of randomized participants: 99
Inclusion criteria: > 18 years of age, undergoing major thoracic operations (pneumectomy, lobectomy, oesophagectomy)
Exclusion criteria: history of asthma, congestive heart failure, ≥ 2nd‐degree heart block, history of SVTs, or were receiving any of the following drugs: digoxin, oral beta‐blocker, quinidine, procainamide, amiodarone, diltiazem, verapamil
Type of surgery: major thoracic operations (pneumectomy, lobectomy, oesophagectomy)
Baseline characteristics
Intervention group (propranolol)
  • Age, mean (SD): 63.3 (± 9.3) years

  • Gender, M/F: 31/18

  • History of MI, %: 8

  • History of hypertension, %: 8

  • History of COPD, n: 10


Control group
  • Age, mean (SD): 61.5 (± 11.3) years

  • Gender, M/F: 30/20

  • History of MI, %: 4

  • History of hypertension, %: 16

  • History of COPD, n: 14


Country: Canada
Setting: hospital, single centre
Interventions Intervention group (propranolol)
  • Randomized, n = 49; losses = 0; analysed, n = 49 (ITT analysis not used)

  • Details: propranolol 10 mg every 6 h; starting before operation and continuing for 5 days postoperatively


Control group (placebo)
  • Randomized, n = 50; losses = 0; analysed, n = 49

  • Details: same an intervention group

Outcomes Outcomes measured/reported by study authors: arrhythmias requiring treatment (until 3 days following surgery, detected by Holter ECG); overall arrhythmia rate, myocardial ischaemia, mortality, bradycardia, hypotension (SBP < 100 mmHg), length of hospital stay, congestive heart failure, bronchospasm
Outcomes relevant to the review: mortality, ventricular arrhythmias, AF, bradycardia (HR ≤ 60 bpm), hypotension, congestive heart failure, length of hospital stay (see notes below),
Notes Funding/declarations of interest: grant from Victoria Hospital Research Foundation and the Canadian Society of Hospital Pharmacists Research Foundation
Study dates: February 1994‐October 1995
Note:
  • we could not combine in analysis data for length of hospital stay because data were reported as median values: propranolol group 12 days (range 9‐38); placebo group 11 days (range 6‐108) (P = 0.42)

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Randomization in blocks of 4, exact method of sequence generation unclear
Allocation concealment (selection bias) Unclear risk Sealed envelopes. No additional details
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk We assumed from the information in the study report that all participants and personnel were blinded to the intervention
Blinding of outcome assessors (detection bias) 
 All outcomes Unclear risk Not specified
Incomplete outcome data (attrition bias) 
 All outcomes Low risk See below
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