Kundra 2008.
Study characteristics | ||
Methods | RCT | |
Participants | 60 women Inclusion criteria: ASA class I and II, single term pregnancies, scheduled for elective caesarean under spinal anaesthesia Exclusion criteria: pre‐existing or pregnancy‐induced hypertension, known cardiovascular disease or contraindications to spinal anaesthesia Setting: India |
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Interventions |
Ephedrine versus crystalloid preload Group 1: ephedrine: ephedrine infusion prepared in 0.9% NS (1 mg/mL), started prophylactically at a rate of 5 mg/min for the first 2 min and then at a rate of 1 mg/min for the next 18 min, following administration of spinal anaesthetic Group 2: crystalloid preload: Ringer's lactate 500 mL, infused rapidly over 15‐20 min before institution of spinal anaesthetic All women received a standardised spinal anaesthetic technique and dose followed by a standardised crystalloid infusion. Hypotension requiring intervention received 5 mg IV bolus ephedrine, repeated if necessary. |
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Outcomes |
Maternal: hypotension; induction to birth time; total ephedrine dose; adverse effects; heart rate Neonatal: Apgar scores; umbilical venous gases |
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Notes | Hypotension was defined as a > 20% fall in SBP | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly divided into two groups" |
Allocation concealment (selection bias) | Unclear risk | Sealed envelope |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Described as "single‐blinded" but unlikely that blinding was possible as women in the ephedrine group had 2 separate IV lines established, while those in the crystalloid group had only 1 line |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not reported |
Incomplete outcome data (attrition bias) All outcomes | Low risk | None reported |
Selective reporting (reporting bias) | Unclear risk | Neonatal outcomes not reported in a form that could be used in this review |
Other bias | Low risk | Similar baseline characteristics |