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 |
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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. |
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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 |
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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 |