Methods |
RCT |
Participants |
Country: Japan N = 60 (enrolled) ASA: I/II Gender: Male/Female 21/25 Age: 18‐70 yr Operation: not specified Duration of anaesthesia: 284±85; 256±172 |
Interventions |
Sevoflurane guided by BIS (A 1050, version 3.4), BIS value of 40‐60 during maintenance and 60‐75 at the end, Cn = 21
Sevoflurane guided by clinical signs (heart rate and blood pressure), Cn = 25
|
Outcomes |
‐Anaesthetic ‐ sevoflurane consumption (ml‐1) ‐Fentanyl required ‐Vecuronium required ‐Time to open eyes on verbal command ‐Time to extubate ‐Time to discharge from the recovery room |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Random sequence generation (selection bias) |
Unclear risk |
Insufficient information |
Allocation concealment (selection bias) |
Unclear risk |
Insufficient information |
Incomplete outcome data (attrition bias) All outcomes |
Unclear risk |
14 subjects were excluded: 11 subjects excluded because surgery was either longer than 6 hrs or shorter than 2 hours, and 3 patients excluded because of mechanical dysfunction of BIS.How these missing data affect on the result is unclear |
Selective reporting (reporting bias) |
Low risk |
All expected outcomes were reported |
Other bias |
Unclear risk |
The unblinded anaesthesiologist could potentially lead to 'learning contamination bias' |
Blinding of patients? |
Low risk |
Patients were anaesthetized |
Blinding of anaesthesiologists? |
High risk |
It was unlikely to blind the anaesthesiologists from the assignment groups because they had to adjust the anaesthetic according to the target BIS values in the BIS group |
Blinding of outcome assessors? |
Unclear risk |
Insufficient information |