De Vivo 2001.
| Methods | RCT, parallel design, Department of Anesthesiology and Intensive Care, University of Naples ‘Federico’, Naples Sample size: details on sample size calculation not mentioned |
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| Participants | Total: 30 participants (17 females; 13 males) Inclusion criteria: ASA I, II, 17 to 75 years of age, scheduled for intracranial supratentorial tumour surgery Exclusion criteria: not mentioned |
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| Interventions | Control: mannitol (18%) Mannitol. Participants in this group had mannitol (0.5 gm/kg as bolus) at the start of the skin incision. During the postoperative period, they received mannitol (0.5 gm/kg daily) 3 times a day for 3 days (72 hours) Hypertonic saline/Mannitol. Participants in this group had mannitol (0.25 gm/kg as bolus) at the start of the skin incision plus 3% HTS, 20 mL/h, in the intraoperative period and mannitol (0.25 gm/kg daily) 3 times a day for 3 days plus HTS in the concentration of 3% on the first day, and 2% and 1% on the second and third days after surgery Hypertonic saline. Participants in this group had 3% HTS (3.5 ml/kg as bolus) at the start of the skin incision plus 3% HTS, 20 mL/h, in the intraoperative period and 3% HTS, 20 mL/h, on the first day and 2% and 1% on the second and third days after surgery |
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| Outcomes |
Dural tension Mean arterial pressure, central venous pressure and heart rate Overall mortality Diuresis, serum osmolality, sodium, potassium, creatinine and urea blood values noted thrice a day |
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| Notes | Hunter's scale (4‐point score) for dural tension (1 = excellent and 4 = impossible dural incision) | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Not mentioned. Study authors contacted. No response |
| Allocation concealment (selection bias) | Unclear risk | Not mentioned. Study authors contacted. No response |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not mentioned. Study authors contacted. No response |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not mentioned. Study authors contacted. No response |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | Data for all participants reported |
| Selective reporting (reporting bias) | Low risk | All outcomes mentioned in methodology are reported |
| Other bias | Low risk | Nothing suggestive |