Vilas Boas 2011.
Methods | RCT, parallel design, Hospital Municipal Odilon Behrens, Brazil Sample size: details on sample size calculation not mentioned |
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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 |
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Interventions | HIS 360 mL/h for 20 minutes Control: 20% mannitol at 750 mL/h for 20 minutes |
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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" |