Caputo 2011.
Methods | Parallel RCT Ethics committee: approved by the Central and South Bristol Research Ethics Committee (registration number E5471) Informed consents: written informed consents were obtained Site: Yale School of Medicine, New Haven, CT, USA; and University of Bristol, Bristol, UK; and Clinica Montevergine, Mercogliano, Italy Setting: university hospital Dates of data collection: August 2003 to November 2007 Funding: funded by the British Heart Foundation Registration: unspecified |
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Participants | 226 participants; mean age 65.7 years; sex distribution: 22 females and 204 males Inclusion criteria
Exclusion criteria
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Interventions |
Intervention
Comparator
Premedication: benzodiazepines Induction: fentanyl, propofol, and pancuronium or vecuronium Maintenance: isoflurane or propofol Surgery: off‐pump CABG |
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Outcomes |
Relevant to this review
Others
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Notes | Correspondence: information received from study authors Conflict of interest: none declared DOI: 10.1093/icvts/ivt001 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized treatment allocations were generated using Stata version 8. Participants were stratified by the consultant team via 1:1 allocation using blocks of varying sizes |
Allocation concealment (selection bias) | Low risk | Allocation details were concealed in sequentially numbered, opaque sealed envelopes. These were prepared by the clinical trials and evaluation unit |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "open" |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Quote: "open" |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All randomized participants were included in the analysis No participants withdrew from the trial |
Selective reporting (reporting bias) | Low risk | All results were reported |
Other bias | Unclear risk | Intention‐to‐treat Epidural anaesthesia: 18 not performed and 9 failed epidural Systemic analgesia: 3 participants received epidural analgesia Groups had similar demographic characteristics, except that lung disease/chronic obstructive airways disease was more common in the epidural group (23% vs 12%) |