Kirov 2011.
Methods | Parallel RCT Ethics committee: study protocol and informed consent form were approved by the Ethics Committee of Northern State Medical University, Arkhangelsk, Russian Federation Informed consents: written informed consent was obtained from every patient Site: Northern State Medical University, Troitsky Avenue 51, Arkhangelsk, 163000, Russian Federation; University of Tromsø, MH‐Breivika, Tromsø, 9038, Norway; and University Hospital of North Norway, Sykehusveien 38, Tromsø, 9038, Norway Setting: university hospital Dates of data collection: from January 2008 to September 2009 Funding: supported by a grant from the Government of Arkhangelsk region, “Young Pomor scientists”, and departmental funds Registration: NCT01384175 |
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Participants | 93 participants; for the participants included in the analysis, mean age: 55.6 years; sex distribution: 42 females and 48 males Inclusion criteria
Exclusion criteria
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Interventions |
Intervention
Comparator
Premedication: diazepam Induction: fentanyl, propofol, and pipecuronium Maintenance: propofol, fentanyl, and pipecuronium 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: study authors declare that they have no competing interests DOI: 10.1186/1471‐2253‐11‐17 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Participants were randomized to 3 groups, using the envelope method |
Allocation concealment (selection bias) | Low risk | Participants were randomized to 3 groups, using the envelope method |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not blinded |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | One participant was withdrawn from analysis in each group due to protocol violation (transfer to CPB) |
Selective reporting (reporting bias) | Low risk | All results reported |
Other bias | Low risk | No failed epidural reported Groups well balanced |