Loughrey 2005.
Study characteristics | ||
Methods | RCT | |
Participants | 43 women Inclusion criteria: ASA I and II non‐labouring women undergoing scheduled elective caesareans; term uncomplicated singleton pregnancies, women taking only prenatal vitamins and weighing less than 100 kg Exclusion criteria: cardiac, pulmonary or renal diseases or systemic diseases that could influence haemodynamic responses, including pre‐eclampsia, hypertension and diabetes; if women were taking or had a history of taking any medications that could influence haemodynamic responses, including magnesium sulphate, terbutaline or B‐blockers |
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Interventions |
Phenylephrine versus control Group 1: 10 mg ephedrine IV Group 2: 40 µg phenylephrine + 10 mg ephedrine The IV bolus of study drug was administered simultaneously with the intrathecal anaesthetic injection. All women received a standardised crystalloid preload, did not wear thromboembolic stockings and received a standardised spinal anaesthetic technique and dose. IV preload with 10 mL/kg of Ringer's lactate; and 10mg IV ephedrine administered simultaneously with study drug For rescue from hypotension, women in the ephedrine only group were given 5 mg ephedrine and women in the ephedrine + phenylephrine group were given 5 mg ephedrine + 20 µg phenylephrine. |
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Outcomes |
Maternal: hypotension; heart rate; nausea; rescue boluses; total mean ephedrine dose; total mean phenylephrine dose Neonatal: umbilical artery pH (mean and SD); umbilical vein pH (mean and SD); Apgar scores at 1 min and 5 min |
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Notes | Hypotension was defined as SBP < 100 mmHg or a decrease in SBP of 20% from baseline | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Method not described |
Allocation concealment (selection bias) | Unclear risk | "Sealed envelope" |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinding: "double‐blinded"; anaesthetist remained blinded to the study solution throughout |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk | Losses to follow‐up: 3/43 – 1 woman in the ephedrine only group and 2 in the ephedrine/phenylephrine group were excluded from analysis due to improper data collection before unblinding |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |