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. 2014 Jun 17;2014(6):CD003843. doi: 10.1002/14651858.CD003843.pub3
Methods RCT
Participants Participants country: Saudi Arabia
N = 30
ASA: I/II 8/7, 10/5
Morbidity obese: body‐mass index of greater than 35
Gender: male/female 9/6, 11/4
Age: 39± 4.50, 41.21± 5.07 years
Exclusion: renal, hepatic or neurological dysfunction or use of benzodiazepines, anticonvulsants, alcohol, opioids or other psychotropic drugs
Operation: gastric banding procedures
Duration of anaesthesia: 136.6±113.7, 138.9±13.8 minutes
Interventions 1) Sevoflurane administration guided by BIS (BIS A‐2000 software 2.21, Aspect Medical Systems, Newton, and Mass), BIS value of 40‐60 during maintenance (BIS group), Cn = 15
2) Sevoflurane administration guided by signs of inadequate anaesthesia (increased blood pressure of greater than 20%, increased heart rate of greater than 90 beats per minutes and other somatic responses) (CS group), Cn = 15
Outcomes Sevoflurane used during maintenance (ml/hr)
Recovery times (min)
‐time to awakening (opening eyes on verbal command)
‐time to extubation
‐time to Aldrete score of 9
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 about the allocation concealment
Incomplete outcome data (attrition bias) All outcomes Unclear risk Insufficiet information regarding withdrawal/dropouts
Selective reporting (reporting bias) Low risk All expected outcome 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 "Group BIS: the anaesthesiologist had access the monitor.." This indicates no blinding of the anaesthesia care provider
Blinding of outcome assessors? Low risk "Blinded study personnel recorded the time ...." This is blinding of outcomes assessors