Whitehead 1980.
Methods | RCT, parallel design | |
Participants |
Total number of randomized participants: 60 Inclusion criteria: scheduled for removal of wisdom teeth under GA Exclusion criteria: cardiac insufficiency, chronic obstructive airway disease, receiving routine medication, diabetes, severe hepatic, renal, or haematological disease Type of surgery: removal of wisdom teeth Baseline characteristics Intervention group (metoprolol)
Control group (placebo)
Country: UK Setting: single centre; hospital |
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Interventions |
Intervention group (metoprolol)
Control group (placebo)
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Outcomes |
Outcomes measured/reported by study authors: cardiac arrhythmias (nodal rhythm and ventricular extrasystoles), bradycardia (HR < 50 bpm); hypotension (SBP < 100 mmHg) Outcomes relevant to the review: bradycardia (HR < 50 bpm); hypotension (SBP < 100 mmHg) |
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Notes |
Funding/declarations of interest: study drugs provided by Messrs Ciba‐Geigy Pharmaceuticals Study dates: not reported |
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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 | Low risk | Randomized, placebo‐controlled, double‐blind trial. Ampoules of study drugs were visually similar |
Blinding of outcome assessors (detection bias) All outcomes | Low risk | Anaesthesiologist evaluating ECG and haemodynamic parameters was blinded to study group allocation |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No apparent losses |
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 | High risk | Short report with baseline characteristics reported with limited detail. Not feasible to assess other risks of bias from this report. In addition, we noted that participants in either group were given metoprolol to manage ventricular dysrrhythmia. This may influence outcome data in the control group |