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

Volk 2003.

Methods Parallel RCT
Ethics committee: approved
Informed consents: written informed consents obtained
Site: Germany
Setting: university hospital
Dates of data collection: unspecified
Funding: unspecified
Registration: unspecified
Participants 26 participants; mean age: 66 years; sex distribution: 5 females and 21 males
Inclusion criteria
  1. Patients undergoing CABG for stable anginal with 3‐vessel disease


Exclusion criteria
  1. LVEF < 0.4; left ventricular end diastolic pressure ≥ 17 mmHg

  2. Clinically significant preexisting pulmonary diseases (determined by clinical examination, chest radiography, lung function tests, and blood gas analyses)

  3. Insulin‐dependent diabetes mellitus

  4. Clinically relevant renal, hepatic, or cerebrovascular disease

  5. Patients with preoperative signs of infection (white cell blood count > 12,000/microlitre, body temperature > 38 degrees C, C‐reactive protein > 5 mg/dL), chronic inflammatory disease

  6. Patients treated with cyclo‐oxygenase inhibitors, ticlopidine, or other drugs inhibiting thrombocyte functions within the last 7 days before the operation

  7. Emergencies

Interventions Intervention
  1. Epidural analgesia (N = 13)


Comparator
  1. Systemic analgesia (N = 13)


Premedication: oral midazolam 0.1 mg/kg
Induction: etomidate 0.2 mg/kg
Maintenance: midazolam, sufentanil, and pancuronium
Surgery: CABG with CPB with a membrane oxygenator
Outcomes Relevant to this review
  1. Pain scores

  2. Haemodynamic variables


Others
  1. Inflammatory response

  2. Stress response

Notes Correspondence: email sent 18 November 2018; no reply
Conflict of interest: not reported
DOI: 10.1016/S1043‐4666(03)00090‐5
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomization was performed using computer‐generated random numbers
Allocation concealment (selection bias) Low risk Sealed opaque envelopes
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes High risk 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 Groups well balanced, except perhaps for sex distribution