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

Scott 2001.

Methods Parallel RCT
Ethics committee: the hospital ethics committee approved the study
Informed consents: all participants gave written informed consent
Site: Glasgow, Scotland, UK
Setting: university hospital
Dates of data collection: unspecified
Funding: departmental/institutional
Registration: unspecified
Participants 408 participants; mean age: 59 years; sex distribution: 56 females and 352 males
Inclusion criteria
  1. Patients undergoing elective CABG

  2. Normal coagulation screen

  3. LVEF > 35%


Exclusion criteria
  1. Abnormal preoperative coagulation screen that included prothrombin time, international normalized ratio, fibrinogen, platelet count, and activated partial thromboplastin time

Interventions Intervention
  1. Epidural analgesia (N = 206)


Comparator
  1. Systemic analgesia (N = 202)


Premedication: temazepam, ranitidine, and metoclopramide
Induction and maintenance: propofol, alfentanil, and pancuronium
Surgery: CABG with CPB
Outcomes Relevant to this review
  1. Risk of mortality

  2. Risk of myocardial infarction

  3. Risk of pulmonary complications (respiratory depression or pneumonia)

  4. Risk of neurological complications (cerebrovascular accident)


Others
  1. Acute confusion

  2. Significant bleeding

  3. Renal failure

  4. Incidence of major organ complications

Notes Correspondence: letter sent 16 March 2018; no reply
Conflict of interest: none reported
DOI: n/a
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: "patients were randomized to one of two regimens...by using cards drawn from a sealed envelope"
Allocation concealment (selection bias) Low risk Sealed envelope
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Study was conducted in an open manner; therefore, neither the anaesthesiologists nor the nurses taking measurements were blinded to participants’ treatment
Blinding of outcome assessment (detection bias) 
 All outcomes High risk Study was conducted in an open manner; therefore, neither the anaesthesiologists nor the nurses taking measurements were blinded to participants’ treatment
Incomplete outcome data (attrition bias) 
 All outcomes Low risk 12 participants had insufficient data
Selective reporting (reporting bias) Low risk All results reported
Other bias Low risk In intention‐to‐treat for remaining 408 participants
Groups had similar demographic data