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

Zawar 2015.

Methods Parallel RCT
Ethics committee: approved by hospital research ethics committee
Informed consents: written informed consents obtained
Site: Institute of Critical Care Anesthesiology, Medanta ‐ The Medicity, Gurgaon, Haryana, India
Setting: tertiary care hospital
Dates of data collection: between December 2011 and November 2014
Funding: departmental resources
Registration: unspecified
Participants 81 participants; mean age: 74.6 years; sex distribution: 9 females and 72 males
Inclusion criteria
  1. Comorbidities (diabetes mellitus, chronic obstructive pulmonary disease, cerebrovascular disease, peripheral vascular disease, renal dysfunction)

  2. Aged ≥ 70 years

  3. Undergoing primary off‐pump CABG


Exclusion criteria
  1. Infection over the spine

  2. Coagulation disorders

  3. Emergency cases

  4. Unstable angina

  5. Left main stem disease

  6. Dysrhythmia

  7. Undergoing combined procedures

  8. On intra‐aortic balloon counter‐pulsation

  9. On antiplatelet agent

  10. Low‐molecular‐weight heparin

  11. Heparin infusion

Interventions Intervention
  1. Epidural analgesia (N = 35)


Comparator
  1. Systemic analgesia (N = 46)


Premedication: lorazepam and pantoprazole
Induction: thiopentone sodium, fentanyl sulfate, and midazolam
Maintenance: isoflurane, fentanyl, midazolam, and pancuronium or vecuronium bromide
Surgery: off‐pump CABG
Outcomes Relevant to this review
  1. Risk of myocardial infarction

  2. Risk of neurological complications (cerebrovascular accident)

  3. Tracheal extubation

  4. Pain scores


Others
  1. Rescue analgesia

  2. Markers of inflammation

  3. Markers of stress response

  4. Blood transfusion requirements

  5. Time to mobilization

  6. Acute kidney injury

  7. ICU length of stay

  8. Hospital length of stay

Notes Correspondence: email sent 16 March 2018; no reply
Conflict of interest: no conflicts of interest
DOI: 10.4103/0971‐9784.159810
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Participants were randomized by computer‐generated numbers
Allocation concealment (selection bias) Low risk Quote: "sealed envelopes"
Blinding of participants and personnel (performance bias) 
 All outcomes High risk This was a non‐blinded study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk This was a non‐blinded study
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk Five protocol violations were reported in participants allocated to the study group. Two epidural catheters were accidentally dislodged during shifting of the participant; 1 participant developed severe hypotension requiring a bolus of epinephrine during catheter placement without any clinical consequences; 1 off‐pump CABG was converted to open CABG due to haemodynamic instability during surgery; and 1 participant withdrew consent from the trial. None of the participants had (quote:) “bloody tap” during epidural catheter placement
Selective reporting (reporting bias) Low risk All results reported
Other bias Low risk Not in intention‐to‐treat
Groups well balanced