Ansari 2011.
Study characteristics | ||
Methods | RCT | |
Participants | 128 women Inclusion criteria: women with a normal singleton pregnancy at 37 weeks' gestation or more scheduled for elective CS Exclusion criteria: ASA grade III or more; height < 150 cm or > 180 cm; body mass < 60 kg or > 100 kg; pre‐eclampsia; known fetal abnormality; or any other contraindication to spinal anaesthesia Setting: United Arab Emirates |
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Interventions |
Phenylephrine 50 μg versus 100 μg infusion Group 1: phenylephrine 50 μg/mL infusion Group 2: phenylephrine 100 μg/mL infusion Phenylephrine infusion was commenced immediately after spinal anaesthesia in conjunction with standardised IV coload with warm Hartmann's solution. Initial phenylephrine rate of 60 mL/h for the first 3 min and stopped if SBP was > 120% of the baseline. After the first 3 min, the infusion was continued at the same rate if SBP was between 80% and 100% of baseline, until the time of giving birth; infusion was discontinued if the SBP was more than 100% of baseline value. All women received standardised aspiration prophylaxis and standardised spinal anaesthetic technique and dose. Hypotension requiring intervention: rescue dose of phenylephrine 50 μg if BP decreased to < 80% baseline for 2 consecutive readings, despite phenylephrine infusion. Bradycardia requiring intervention: if bradycardia without hypotension, phenylephrine infusion was discontinued for 1 min; if bradycardia developed with hypotension, IV glycopyrronium 200 μg was administered. |
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Outcomes |
Maternal: BP; hypotension; hypertension; bradycardia; total dose of phenylephrine; nausea and vomiting Neonatal: Apgar scores at 1 min and 5 min; umbilical arterial pH and gases |
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Notes | Hypotension defined as SBP < 80% baseline Hypertension defined as SBP > 120% baseline Bradycardia defined as heart rate < 50 bpm |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomised" – no further details reported |
Allocation concealment (selection bias) | Unclear risk | "Closed similar" envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | An anaesthetist who was not involved in case management prepared a 20 mL syringe for phenylephrine infusion with the designated concentration; both women and the anaesthetist in charge of the case were blinded to the concentration of phenylephrine in the syringe |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported, but likely in view of the above. |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | 11/128 lost to follow‐up (not reported by assigned group):
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Selective reporting (reporting bias) | Low risk | Most expected outcomes were reported. |
Other bias | Unclear risk | Some suggestion of imbalance in randomisation and/or differential losses to follow‐up (54 and 63 women analysed in each group) |