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

Sen 2017.

Methods Parallel RCT
Ethics committee: approved by the ethical committee of the hospital
Informed consents: obtained
Site: Amrita Institute of Medical Sciences, Amrita Vishwa Vidyapeetham, Kochi, Kerala, India
Setting: university hospital
Dates of data collection: unspecified
Funding: departmental resources
Registration: unspecified
Participants 60 participants; mean age: not reported; sex distribution: not reported
Inclusion criteria
  1. Male

  2. ASA III participants

  3. Aged 45 to 70 years

  4. Posted for CABG surgery for triple‐vessel disease

  5. APTT ≤ 45 seconds prothrombin time (PT) (international normalized ratio (INR) ≤ 1.5), platelets ≥ 80,000/dL

  6. Good left ventricular systolic function ejection fraction (EF) > 50%

  7. Had discontinued aspirin and clopidogrel 7 days preoperatively


Exclusion criteria
  1. Patient refusal

  2. Infection at puncture site

  3. APTT ≥ 45 seconds

  4. PT (INR) = 1.5

  5. Platelets ≤ 80,000/dL

  6. Clopidogrel within last 7 days of the procedure

  7. Coexisting liver disease

Interventions Intervention
  1. Epidural analgesia (N = 30)


Comparator
  1. Fentanyl infusion (N = 30)


Premedication: lorazepam, ranitidine, allopurinol, vitamin C, vitamin A, and vitamin E
Induction and maintenance: fentanyl, midazolam, and pancuronium
Surgery: CABG with CPB using a membrane oxygenator
Outcomes Relevant to this review
  1. Risk of pulmonary complications (respiratory depression)

  2. Risk of neurological complications (serious neurological complications from epidural analgesia)

  3. Pain scores

  4. Haemodynamic variables


Others
  1. Rescue analgesia

  2. Sedation scores

  3. Co‐operation to physiotherapy

Notes Correspondence: email sent 16 March 2018; no reply
Conflict of interest: no conflicts of interest
DOI: 10.4103/0259‐1162.186613
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomly allocated to 2 equal groups by computer‐generated random sequence of numbers
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Study was a prospective, randomized, non‐blinded comparative study
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Study was a prospective, randomized, non‐blinded comparative study
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 No failed epidural reported
Groups well balanced