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)
Control group (standard care)
Country: Belgium Setting: single centre; hospital |
|
Interventions |
Intervention group (sotalol)
Control group (standard care)
|
|
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:
|
|
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 |