Skip to main content
. 2019 Mar 1;2019(3):CD006715. doi: 10.1002/14651858.CD006715.pub3

Jakobsen 2012.

Methods Parallel RCT
Ethics committee approval: approved by the Central Denmark Region Committee on Biomedical Research Ethics and the Danish Medicine Agency
Informed consents: written informed consents were obtained from all participants
Site: Aarhus University Hospital, Skejby, Aarhus, Denmark
Setting: university hospital
Dates of data collection: unspecified
Funding: unspecified
Registration: Eudra CT 2005‐000617‐35
Participants 60 participants; mean age: 71.3 years; sex distribution: 21 females and 39 males
Inclusion criteria
  1. Low‐ to moderate‐risk participants between the ages of 65 and 80 years scheduled for CABG with or without AVR


Exclusion criteria
  1. Ejection fraction < 0.3

  2. Myocardial infarction within the last 4 weeks

  3. Diabetes

  4. Severe pulmonary or arterial hypertension

  5. Contraindication for TEA

  6. No preoperative optimal echocardiographic imaging

Interventions Intervention
  1. Epidural analgesia (N = 30)


Comparator
  1. Systemic analgesia (N = 30)


Induction and maintenance: propofol or sevoflurane, sufentanil, and rocuronium
Surgery: CABG, valve procedure, or both with CPB, using a hollow‐fibre membrane oxygenator
Outcomes Relevant to this review
  1. Risk of mortality

  2. Risk of myocardial infarction

  3. Risk of neurological complication: cerebrovascular accident

  4. Time to tracheal extubation

  5. Haemodynamic variables


Others
  1. Rescue analgesics

  2. Acute kidney injury: renal function expressed as changes in s‐creatinine: fewer TEA patients (13.3% vs 36.7%; P = 0.074, Chi² test) developed acute kidney injury

  3. ICU length of stay (hours from arrival in the ICU to discharge to the surgical ward)

  4. Time to eligible to ICU discharge (predefined scoring system evaluated at regular intervals)

  5. Hospital length of stay

Notes Conflict of interest: study authors declare that they have no competing interests
Correspondence: email sent 16 March 2018; no reply
DOI: 10.1053/j.jvca.2012.05.007 and 10.1053/j.jvca.2012.05.008
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization by the standard envelope method with blocks of 20 participants was performed immediately before insertion of the epidural catheter the day before surgery
Allocation concealment (selection bias) Low risk Randomization by the standard envelope method with blocks of 20 participants was performed immediately before insertion of the epidural catheter the day before surgery
Blinding of participants and personnel (performance bias) 
 All outcomes Unclear risk Not reported
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Sixty‐three patients were approached; 2 declined, and 1 was excluded because surgery was changed to off‐pump CABG surgery
Selective reporting (reporting bias) Unclear risk Quote: "there were no significant differences in blood loss, urine output, administration of crystalloids and adverse events (not shown)"
Other bias Low risk Groups well balanced for preoperative characteristics
One participant in the TEA group did not receive a functional epidural, but because the protocol was based on an intention‐to‐treat principle, this participant was analysed in the TEA group