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

Tenenbein 2008.

Methods Parallel RCT
Ethics committee: approved by the Ethics Review Board of the University of Manitoba Health Sciences Centre
Informed consents: all participants gave written informed consent
Site: University of Manitoba, Canada
Setting: university hospital
Dates of data collection: between July 1, 2003, and June 30, 2004
Funding: supported by the Health Sciences Centre Research Foundation
Registration: not registered
Participants 50 participants; mean age: 60.5 years; sex distribution: not reported
Inclusion criteria
  1. Patients younger than 80 years of age

  2. Deemed appropriate for their facilitated recovery programme

  3. Undergoing CABG surgery


Exclusion criteria
  1. Age 80 years or older

  2. Previous cardiac surgery

  3. Combined procedures

  4. Serum creatinine > 150 mmol/L

  5. Pre‐existing coagulopathy

  6. Use of antiplatelet agents other than aspirin

  7. Active liver disease

  8. Severe spinal deformity

  9. Ejection fraction < 30%

  10. Body mass index > 35 kg/m²

Interventions Intervention
  1. Epidural analgesia (N = 25)


Control
  1. Systemic analgesia (N = 25)


Premedication: diazepam
Induction: sufentanil, sodium thiopental, or propofol and rocuronium
Maintenance: isoflurane
Surgery: CABG with CPB
Outcomes Relevant to this review
  1. Risk of mortality

  2. Risk of pulmonary complications (respiratory depression, pneumonia)

  3. Risk of atrial fibrillation or atrial flutter

  4. Risk of neurological complications (cerebrovascular accident, serious neurological complications from epidural analgesia)

  5. Tracheal extubation

  6. Pain scores


Others
  1. Rescue analgesia

  2. Lung function tests

Notes Correspondence: information received from study authors
Conflict of interest: no conflicts of interest
DOI: 10.1007/BF03021489
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "prospective, randomized, controlled trial"; "Randomization occurred immediately after enrolment"; "assigned a sealed envelope that contained the group assignment"
Allocation concealment (selection bias) Low risk Quote: "assigned a sealed envelope that contained the group assignment"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Quote: "this was not a blinded study"
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Quote: "this was not a blinded study"
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Quote: "Due to incomplete data collection, two patients were excluded from each group"; "unable to insert an epidural in one patient, and the epidural was not use, postoperatively in another patient, because of quadriparesis on emergence"
Selective reporting (reporting bias) Low risk All results reported
Other bias Low risk Quote: "intention to treat principle"
Preoperatively, groups were similar, except for higher mean ejection fractions in the control group (59.1 ± 8.9% vs 52.9 ± 7.5%; P < 0.01)