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 |
Isoflurane administration guided by BIS (Aspect A‐1000, version 3.1) of 45 to 55
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 |