Myles 2002.
Methods | Parallel 3‐arm double‐blinded randomized controlled trial, conducted in Australia. Study dates not reported | |
Participants | 87 elective coronary artery bypass patients younger than 75 years of age. Excluded were those with body weight > 100 kg, allergic to trial medications, at high risk of mortality, uncontrolled hypertension or hypotension, congestive cardiac failure or an ejection fraction < 25%, with atrioventricular or left bundle branch block detected on preoperative electrocardiogram or with a pacemaker in situ. | |
Interventions | Low‐dose opioid (propofol and mean fentanyl 15 μg/kg) in 24 participants High‐dose opioid (propofol and mean fentanyl 28 μg/kg) in 24 participants Details of who decided when to extubate were not given. |
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Outcomes | Risk of postoperative myocardial infarction (new Q waves in ≥ 2 ECG leads as detected by an independent and blinded cardiologist) Risk of wound infection (unpublished) Risk of stroke Risk of acute renal failure (requiring dialysis or haemofiltration) (unpublished) Time to extubation in ICU Length of stay in ICU Length of hospital stay (unpublished) Total hospital cost (OT drug cost, OT other cost, ICU total cost) |
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Notes | Data from remifentanil (0.85 μg/kg/min) were not included as they did not fit the criteria for the early extubation group nor the conventional extubation group (as per correspondence with Prof Myles). Complete total hospital cost data were available for 46 participants (high cost outliers in 3 participants not included in analysis). Power calculation was done. First study author was supported by a National Health and Medical Research Council Practitioner Fellowship award; study was supported by the Alfred Hospital Wholetime Medical Specialists Scheme and Glaxo Wellcome. Details of any declarations of conflict of interest among study authors were not provided. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization code was created by table of random numbers, and participants were stratified to high‐ or low‐risk groups. |
Allocation concealment (selection bias) | Unclear risk | No details given |
Blinding (performance bias and detection bias) All outcomes | Low risk | "The clinical trial unit or hospital pharmacy department who prepared solutions according to the randomization code maintained blinding of the study drug preparations" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 87 participants were enrolled, and 10 participants were excluded (1 participant withdrew consent before surgery, 2 had their surgery deferred and 7 failed to receive their allotted study medication) |
Selective reporting (reporting bias) | Low risk | All outcomes collected and reported |
Other bias | Low risk | Perioperative factors were similar between groups. |