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. 2020 Jul 1;2020(7):CD002251. doi: 10.1002/14651858.CD002251.pub4

Das Neves 2010.

Study characteristics
Methods RCT
Participants 120 women
Inclusion criteria: physical status ASA I, with an indication for elective CS, singleton term pregnancy
Exclusion criteria: history of hypertension or pregnancy‐induced hypertension, cardiovascular or cerebrovascular disease, fetal abnormalities, history of hypersensitivity to the drugs used in the study, and contraindications to spinal block
Setting: Brazil
Interventions Phenylephrine: prophylactic infusion versus therapeutic dosing
Group 1: continuous IV infusion of phenylephrine, using a 1‐channel "Baxter" volumetric infusion pump (containing a solution of 10 mL of NS with 10 mg phenylephrine (100 μg/mL)), at 0.15 μg/kg/min, which was started immediately after the spinal block
Group 2: a single dose of phenylephrine, 50 μg IV, administered immediately after the spinal block.  Baxter volumetric infusion pump connected, containing 100 mL NS
Group 3: a single dose of phenylephrine, 50 μg IV, administered in case of hypotension, defined as a fall in SBP and/or DBP of up to 20% of mean baseline levels.  Baxter volumetric infusion pump connected, containing 100 mL NS
All women received a standardised spinal anaesthetic technique and dose followed by a standardised crystalloid infusion and standardised positioning.
Hypotension treatment involved a bolus of 30 μg of phenylephrine IV repeated every 2 min if a drop in BP > 20% that was not controlled with the therapeutic regimen used.
Bradycardia was treated when associated with hypotension with 0.5 mg of atropine IV.
Outcomes Maternal: hypotension; reactive hypertension; bradycardia; nausea and vomiting
Neonatal: Apgar score < 8 at 5 min
Notes Hypotension defined as a drop in SBP and/or DBP > 20% of mean baseline levels
Reactive hypertension defined as BP 20% > mean baseline levels after the use of the vasopressor
Bradycardia defined as heart rate lower than 50 bpm
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated numbers
Allocation concealment (selection bias) Unclear risk Sequential sealed envelopes
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk "Double blind."  Patients, and physicians responsible for collecting and analysing the data were blinded; anaesthetist administering the anaesthesia was not blinded.  This anaesthetist was not involved in data collection and analysis.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Those collecting and analysing the data were blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk No losses to follow‐up occurred
Selective reporting (reporting bias) Low risk None apparent
Other bias Unclear risk No apparent sources of other bias