Bhardwaj 2013.
Study characteristics | ||
Methods | RCT | |
Participants | 90 women Inclusion criteria: ASA grade I, elective CS under spinal anaesthesia, singleton pregnancy, no fetal abnormalities, no pre‐eclampsia, no cerebrovascular diseases Setting: India |
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Interventions |
Phenylephrine infusion versus ephedrine infusion versus metaraminol infusion Group 1: phenylephrine 30 μg/mL (15 μg/min) Group 2: ephedrine 5 mg/mL (2.5 mg/min) Group 3: metaraminol 0.5 mg/mL (0.25 mg/min) Immediately following SAB, patients received 1 mL bolus of study drug and then a infusion at 15 mL/h All women received standardised: aspiration prophylaxis, monitoring, IV cannulation, isotonic saline coload, spinal anaesthetic technique and dose If SBP increased 1.25 times above baseline, infusion was ceased. If SBP dropped 10% below the baseline, 1 mL bolus of study drug given. If maternal heart rate < 60 bpm and SBP < 80% of baseline, or if maternal heart rate < 50 and SBP < 100% of baseline, or if maternal heart rate < 45 regardless of BP, glycopyrrolate 0.2 mg IV given |
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Outcomes |
Maternal: incidence of maternal hypotension, incidence of maternal hypertension, heart rate, nausea/vomiting, total dose of vasopressor Neonatal: Apgar scores at 1 min and 5 min, umbilical cord gases |
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Notes | Hypotension: SBP < 80% of baseline Hypertension: SBP > 120% of baseline |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomised sequence |
Allocation concealment (selection bias) | Low risk | Sequentially numbered sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blind Study drugs prepared by another anaesthetist not involved in other aspects of the participants' care, into a unlabelled 20 mL syringe |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Below exclusions reported: Group 2 – 1 failed SAB Group 3 – 1 failed SAB Group 1 – 2 pump failures |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |