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

Palomero 2008.

Methods Parallel RCT
Ethics committee: approved by the La Paz Hospital Human Research Ethics Committee
Informed consents: written informed consents were obtained from all patients
Site: La Paz University Hospital, Madrid, Spain; and Gregorio Marañon University Hospital, Madrid, Spain
Setting: university hospital
Dates of data collection: not reported
Funding: departmental
Registration: unspecified
Participants 22 participants; mean age: 65.3 years; sex distribution: 4 females and 18 males
Inclusion criteria
  1. Patients undergoing elective coronary artery bypass graft surgery


Exclusion criteria
  1. History of inflammatory disease

  2. Recent infection

  3. Autoimmune disease

  4. Corticoid treatment

  5. Immunosuppressant treatment

  6. Recent preoperative procedure

  7. Recent emergency procedure

  8. Concurrent valvular surgery or presence of valvular disease

  9. Ejection fraction (EF) < 45%

  10. Older than 85 years

Interventions Intervention
  1. Epidural analgesia (N = 10)


Comparator
  1. No epidural (N = 12)


Induction: propofol, fentanyl, and vecuronium
Maintenance: propofol, sevoflurane, and fentanyl or epidural analgesia
Surgery: CABG with CPB
Outcomes Relevant to this review
  1. Risk of myocardial infarction

  2. Risk of atrial fibrillation or atrial flutter

  3. Risk of neurological complications (cerebrovascular accident or epidural haematoma or abscess)

  4. Tracheal extubation

  5. Haemodynamic variables


Others
  1. Markers of inflammation

  2. Blood transfusion requirement

Notes Correspondence: information received from study authors
Conflict of interest: no conflict of interest
DOI: n/a
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "assigned a computer‐generated randomization code"
Allocation concealment (selection bias) Low risk Quote: "final randomization was performed by a physician not belonging to the hospital team the day before surgery, using the randomization code"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "the study was not blinded"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "the study was not blinded"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk No loss to follow‐up
Selective reporting (reporting bias) Low risk All results reported
Other bias Low risk No failed epidural reported
Groups well balanced, except Euroscore was higher in the TEA group (5.4 vs 3.8)