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. 2014 Jul 16;2014(7):CD010026. doi: 10.1002/14651858.CD010026.pub2

Vilas Boas 2011.

Methods RCT, parallel design, Hospital Municipal Odilon Behrens, Brazil
Sample size: details on sample size calculation not mentioned
Participants Total: 29 adult patients, ASA I/II (female; male)
Age [mean (standard deviation)]: mannitol group: 44 (3.34) years; HIS group: 49.5 (4.52) years
Gender (male/female): mannitol group: 8/9; HIS group: 6/6
Inclusion: patients undergoing elective craniotomy and cerebral aneurysm clipping, arteriovenous malformations or cerebral tumours (4 in mannitol group and 5 in HIS group)
Exclusion: age < 21 years, initial serum Na < 130 or > 150 mEq/L, metabolic disorders, treatment with hyperosmotic solution up to 24 hours before surgery or history of past heart or renal failure
Interventions HIS 360 mL/h for 20 minutes
Control: 20% mannitol at 750 mL/h for 20 minutes
Outcomes Brain bulk
Notes 4‐point scale: 1 = perfect relaxation; 2 = satisfactory relaxation; 3 = firm brain; 4 = swollen brain
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No appropriate information provided
Allocation concealment (selection bias) Unclear risk No appropriate information provided
Blinding of participants and personnel (performance bias) 
 All outcomes High risk The anaesthetist was not blinded
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Quote: "Cerebral relaxation was evaluated by the same surgeon who was blind to the hyperosmolar therapy used….."
Comment: probably done
Incomplete outcome data (attrition bias) 
 All outcomes Low risk Data on all participants reported
Selective reporting (reporting bias) Low risk All outcomes mentioned in the methodology have been reported
Other bias High risk Communication: "Isoncotic Hypertonic Solution was a donation by the Fresenius Kabi AG"