Singh 2016.
Study characteristics | ||
Methods | RCT | |
Participants | 50 women Inclusion criteria: primiparous, full‐term parturients, aged 18‐40 years, ASA I, scheduled for elective CS Exclusion criteria: refusal of regional anaesthesia, contraindications to spinal anaesthesia, fetal abnormalities, known allergy to any of the drugs used in the study, pregnancy‐induced hypertension or parturients with SBP > 140 mmHg, history of diabetes mellitus, cardiovascular or cerebrovascular and any chronic diseases Setting: India |
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Interventions | Ephedrine versus control Group 1: 1 mL 5 mg ephedrine IV immediately after SAB Group 2: 1 mL 0.9% NaCl IV immediately after SAB All women received standardised monitoring, standardised crystalloid IV fluid, standardised spinal anaesthetic technique and dose. Treatment of hypotension involved rapid infusion of Ringer's lactate and 5 mg IV ephedrine. Bradycardia treated with 0.6 mg IV atropine sulfate. |
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Outcomes |
Maternal: incidence of hypotension, reactive hypertension, number of patients requiring rescue ephedrine, total dose of rescue ephedrine (mg), bradycardia, nausea/vomiting, average time to delivery Neonatal: Apgar scores at 1 min and 5 min |
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Notes | Hypotension was defined as a decrease in SBP of > 20% Bradycardia was defined as heart rate < 60 bpm Reactive hypertension: SBP > 140 mmHg |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded. Study solution prepared by person not involved in the study |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Study staff recorded outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All patients completed protocol |
Selective reporting (reporting bias) | Low risk | Not evident |
Other bias | Unclear risk | None evident |