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 |
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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. |
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Outcomes |
Maternal: hypotension; reactive hypertension; bradycardia; nausea and vomiting Neonatal: Apgar score < 8 at 5 min |
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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 |
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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 |