Jakobsen 2012.
Methods | Parallel RCT Ethics committee approval: approved by the Central Denmark Region Committee on Biomedical Research Ethics and the Danish Medicine Agency Informed consents: written informed consents were obtained from all participants Site: Aarhus University Hospital, Skejby, Aarhus, Denmark Setting: university hospital Dates of data collection: unspecified Funding: unspecified Registration: Eudra CT 2005‐000617‐35 |
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Participants | 60 participants; mean age: 71.3 years; sex distribution: 21 females and 39 males Inclusion criteria
Exclusion criteria
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Interventions |
Intervention
Comparator
Induction and maintenance: propofol or sevoflurane, sufentanil, and rocuronium Surgery: CABG, valve procedure, or both with CPB, using a hollow‐fibre membrane oxygenator |
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Outcomes |
Relevant to this review
Others
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Notes | Conflict of interest: study authors declare that they have no competing interests Correspondence: email sent 16 March 2018; no reply DOI: 10.1053/j.jvca.2012.05.007 and 10.1053/j.jvca.2012.05.008 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomization by the standard envelope method with blocks of 20 participants was performed immediately before insertion of the epidural catheter the day before surgery |
Allocation concealment (selection bias) | Low risk | Randomization by the standard envelope method with blocks of 20 participants was performed immediately before insertion of the epidural catheter the day before surgery |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Sixty‐three patients were approached; 2 declined, and 1 was excluded because surgery was changed to off‐pump CABG surgery |
Selective reporting (reporting bias) | Unclear risk | Quote: "there were no significant differences in blood loss, urine output, administration of crystalloids and adverse events (not shown)" |
Other bias | Low risk | Groups well balanced for preoperative characteristics One participant in the TEA group did not receive a functional epidural, but because the protocol was based on an intention‐to‐treat principle, this participant was analysed in the TEA group |