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

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
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.
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
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