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

Kirov 2011.

Methods Parallel RCT
Ethics committee: study protocol and informed consent form were approved by the Ethics Committee of Northern State Medical University, Arkhangelsk, Russian Federation
Informed consents: written informed consent was obtained from every patient
Site: Northern State Medical University, Troitsky Avenue 51, Arkhangelsk, 163000, Russian Federation; University of Tromsø, MH‐Breivika, Tromsø, 9038, Norway; and University Hospital of North Norway, Sykehusveien 38, Tromsø, 9038, Norway
Setting: university hospital
Dates of data collection: from January 2008 to September 2009
Funding: supported by a grant from the Government of Arkhangelsk region, “Young Pomor scientists”, and departmental funds
Registration: NCT01384175
Participants 93 participants; for the participants included in the analysis, mean age: 55.6 years; sex distribution: 42 females and 48 males
Inclusion criteria
  1. ASA III adult patients with coronary artery disease

  2. ASA III and scheduled for elective off‐pump coronary artery bypass grafting


Exclusion criteria
  1. Age < 18 years

  2. Severe valve dysfunction

  3. Peripheral vascular disease

  4. Simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.)

  5. Transfer to CPB during surgery

Interventions Intervention
  1. Epidural analgesia as a continuous infusion (N = 31) or as PCEA (N = 31)


Comparator
  1. Systemic analgesia (N = 31)


Premedication: diazepam
Induction: fentanyl, propofol, and pipecuronium
Maintenance: propofol, fentanyl, and pipecuronium
Surgery: off‐pump CABG
Outcomes Relevant to this review
  1. Risk of mortality at 28 days

  2. Risk of myocardial infarction (troponin‐T)

  3. Risk of atrial fibrillation or atrial flutter (no difference between groups)

  4. Tracheal extubation

  5. Pain scores

  6. Haemodynamic variables


Others
  1. Sedation scores

  2. ICU length of stay

  3. Hospital length of stay

Notes Correspondence: information received from study authors
Conflict of interest: study authors declare that they have no competing interests
DOI: 10.1186/1471‐2253‐11‐17
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomized to 3 groups, using the envelope method
Allocation concealment (selection bias) Low risk Participants were randomized to 3 groups, using the envelope method
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 One participant was withdrawn from analysis in each group due to protocol violation (transfer to CPB)
Selective reporting (reporting bias) Low risk All results reported
Other bias Low risk No failed epidural reported
Groups well balanced