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

Kurian 2001.

Methods RCT, parallel design
Participants Total number of randomized participants: 72
Inclusion criteria: scheduled for coronary artery surgery
Exclusion criteria: conditions that would make ST segment monitoring unreliable (digoxin therapy, left ventricular hypertrophy, left bundle branch block, presence of a pacemaker), contraindications to beta‐adrenoceptor blocker, asthma, intolerance to beta‐adrenergic blockade, 1st‐degree heart block, beta‐adrenergic agonist infusion at start of study, preoperative serum creatinine > 120 µmol/L
Type of surgery: elective CABG
Baseline characteristics
Intervention group (esmolol)
  • Age, mean (SD): 60.2 (± 6.69) years

  • Gender, M/F: 25/6


Control group (standard care)
  • Age, mean (SD): 61.1 (± 7.47)

  • Gender, M/F: 33/4


Country: UK
Setting: single centre; hospital
Interventions Intervention group (esmolol)
  • Randomized, n = 34; losses = 3 (1 due to technical faults in recording equipment; 2 due to hypotension); analysed, n = 31 (ITT analysis not used)

  • Details: treatment was started 120 min before extubation and was continued until 180 min after extubation; loading dose of 500 µg/kg/min for 1 min at discretion of clinician at beginning or to gain or regain control or HR. IV esmolol given at a dose to maintain HR in range of 55‐75 bpm


Control group (standard care)
  • Randomized, n = 38; losses = 1 (due to technical faults in recording equipment); analysed, n = 37

  • Details: standard care

Outcomes Outcomes measured/reported by study authors: haemodynamic variables, discontinuation of treatment due to hypotension (not defined), perioperative myocardial ischaemia (120 min before until 180 min after tracheal extubation)
Outcomes relevant to the review: hypotension (see notes below)
Notes Funding/declarations of interest: not reported
Study dates: not reported
Notes:
  • we noted that 2 participants in the intervention group had hypotension. We did not include these in analysis because it was not certain whether events were measured in the control group

  • early termination of trial due to many adverse events and problems in participant recruitment

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not specified
Allocation concealment (selection bias) Low risk Numbered, sealed envelopes, provided by hospital pharmacy
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 Low risk 4 participants were withdrawn (2 because of hypotension in the esmolol group, 1 in the esmolol group and 1 in the control group because of insufficient monitoring). Clearly reported, < 10% loss
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