Fillinger 2002.
Methods | Parallel RCT Ethics committee: approved by the Dartmouth College Committee for Protection of Human Subjects (institutional review board) Informed consents: written, informed consents were obtained from all participants Site: Dartmouth‐Hitchcock Medical Center, Lebanon; and Dartmouth Medical School, Hanover, NH, USA Setting: university hospital Dates of data collection: unspecified Funding: unspecified Registration: unspecified |
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Participants | 60 participants; mean age: 62.8 years; sex distribution: 10 females and 50 males Inclusion criteria
Exclusion criteria
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Interventions |
Intervention
Comparator
Premedication: fentanyl and midazolam Induction: fentanyl, midazolam, thiopental, and pancuronium or vecuronium Maintenance: isoflurane Surgery: CABG with CPB using a membrane oxygenator |
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Outcomes |
Relevant to this review
Others
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Notes | Correspondence: letter sent 16 March 2018; no reply Conflict of interest: not reported DOI: 10.1053/jcan.2002.29639 |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "computerized randomization" (as classified by previous review authors) |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Quote: "nonblinded" |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Quote: "nonblinded" Except for ECG: recordings were reviewed by one of the study authors and a cardiologist, both of whom were blinded to treatment |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No loss to follow‐up |
Selective reporting (reporting bias) | Low risk | All prespecified outcomes reported |
Other bias | Unclear risk | Two participants in the epidural group were withdrawn from treatment in the operating room: 1 because of inability to place the catheter and 1 because of intravascular migration of an initially functioning catheter Both were included in subsequent analyses as intention‐to‐treat Groups had similar demographic data, except that 11 participants in the epidural group had a history of myocardial infarction within the 3 months immediately preceding surgery compared with 2 participants in the systemic analgesia group (P < 0.005) |