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

Tsen 2000.

Study characteristics
Methods RCT
Participants 40 women
Inclusion criteria: ASA I and II women not in labour undergoing elective caesarean for term uncomplicated singleton pregnancies, taking only prenatal vitamins and weighing less than 100 kg
Exclusion criteria: women with 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 beta‐blockers
Interventions Ephedrine versus control
Group 1: ephedrine 2 mL IV (10 mg) given simultaneously with spinal anaesthetic
Group 2: saline 2 mL IV given simultaneously with spinal anaesthetic
All women received a standardised crystalloid preload and a standardised spinal anaesthetic technique and dose, followed by standardised surgical positioning.
Hypotension was treated with 10 mg IV doses of ephedrine.
Outcomes Maternal: hypotension; MAP; heart rate; tachycardia (ephedrine group only); hypertension (ephedrine group only); systemic vascular resistance index; stroke index; cardiac index
Neonatal: Apgar score < 8 at 5 min
Notes Hypotension was defined as 20% decrease in MAP
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 envelopes
Blinding of participants and personnel (performance bias)
All outcomes Unclear risk Blinding: double‐blind – Apgar scored by a paediatrician blinded to the study – no further details
Blinding of outcome assessment (detection bias)
All outcomes Unclear risk As above
Incomplete outcome data (attrition bias)
All outcomes Low risk No losses to follow‐up
Selective reporting (reporting bias) Low risk Not apparent
Other bias Low risk Not apparent