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. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3
Methods RCT
Participants Country: India N = 30, ASA: III or greater Gender: no information Age: 38.25±14.02, 32.08±13.84 Inclusion: undergoing either coronary artery grafting (CAGB) or valve replacement under cardiopulmonary bypass (CP) Exclusion: neurological disorders, poor ventricular function, New York Heart Association grade IV, diabetes mellitus, and impaired renal or hepatic function Operation: coronary artery grafting (CAGB) or valve replacement under cardiopulmonary bypass (CP) Duration of surgery: 295±45, 285±40 minutes
Interventions
  1. Isoflurane administration guided by BIS (Aspect A‐1000, version 3.1) of 45 to 55

  2. Isoflurane administration guided by clinical signs

Outcomes Number of haemodynamic disturbances: hypertension, tachycardia, hypotension, bradycardia Recovery endpoint ‐ time from switching off anaesthetic vaporizer to opening eyes or response to verbal commands Time to tracheal extubation Awareness*
Notes
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "......were randomized into ......using computer‐generated numbers." This indicate adequate sequence generation
Allocation concealment (selection bias) Unclear risk Insufficient information about the allocation concealment
Incomplete outcome data (attrition bias) All outcomes Low risk From table 1 of the study, it is likely that all patients were included in the analysis
Selective reporting (reporting bias) Low risk All expected outcomes are reported
Other bias Unclear risk The unblinded anaesthesiologist could potentially lead to 'learning contamination bias'
Blinding of patients? Low risk All patients were anaesthetized
Blinding of anaesthesiologists? High risk "In the study group, the anaesthesiologist was allowed to see and use the monitor.." This indicates no blinding of anaesthesia care providers
Blinding of outcome assessors? Unclear risk Insufficient information regarding blinding of outcome assessors