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. 2019 Mar 1;2019(3):CD006715. doi: 10.1002/14651858.CD006715.pub3

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
Participants 60 participants; mean age: 62.8 years; sex distribution: 10 females and 50 males
Inclusion criteria
  1. Scheduled for elective CABG


Exclusion criteria
  1. Absence of any specific contraindication to the use of heparin or warfarin anticoagulation

  2. Pre‐existing coagulopathy

  3. Infection at insertion site

  4. Septicaemia

Interventions Intervention
  1. Epidural analgesia (N = 30)


Comparator
  1. Systemic analgesia (N = 30)


Premedication: fentanyl and midazolam
Induction: fentanyl, midazolam, thiopental, and pancuronium or vecuronium
Maintenance: isoflurane
Surgery: CABG with CPB using a membrane oxygenator
Outcomes Relevant to this review
  1. Risk of mortality

  2. Risk of myocardial infarction

  3. Risk of atrial fibrillation or atrial flutter

  4. Risk of neurological complications (cerebrovascular accidents)

  5. Tracheal extubation

  6. Pain scores


Others
  1. Length of hospital stay

Notes Correspondence: letter sent 16 March 2018; no reply
Conflict of interest: not reported
DOI: 10.1053/jcan.2002.29639
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Other bias Unclear risk Two participants in the epidural group were withdrawn from treatment in the operating room: 1 because of inability to place the catheter and 1 because of intravascular migration of an initially functioning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)