Nazir 2012.
Study characteristics | ||
Methods | RCT | |
Participants | 100 women Inclusion criteria: ASA grade I women undergoing elective CS under spinal anaesthesia with a normal singleton pregnancy beyond 36 weeks' gestation Exclusion criteria: pregnancy‐induced hypertension, diabetes, cardiovascular or cerebrovascular disease, fetal abnormalities, contraindication to spinal anaesthesia Setting: India |
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Interventions |
Prophylactic ephedrine versus phenylephrine Group 1: prophylactic bolus of ephedrine 10 mg IV 1 min after intrathecal injection Group 2: prophylactic dose of phenylephrine 100 μg IV 1 min after intrathecal injection All women received standardised premedication, a standardised fluid preload, a standardised spinal anaesthetic technique (in either lateral or seated position) and dose, standardised surgical positioning. Hypotension managed with rescue boluses of ephedrine 5 mg IV (group 1) or phenylephrine 50 μg IV (group 2) whenever maternal SBP was recorded as less than 90 mmHg. Bradycardia was treated with atropine 300 μg IV bolus. |
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Outcomes |
Maternal: BP (systolic, diastolic, mean); heart rate; need for rescue bolus(es); need for atropine Neonatal: Apgar scores at 1 min and 5 min; umbilical cord blood pH (unclear as to venous or arterial); results for Apgar and pH < 7.2 |
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Notes | Definition of hypotension is a SBP measurement < 90 mmHg. Bradycardia was defined as heart rate < 60 bpm. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | "Randomly allocated into two groups of 50 each" – method not specified |
Allocation concealment (selection bias) | Unclear risk | "Randomly allocated into two groups of 50 each" – method not specified |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double blind" – the vasopressor solutions were prepared in identical syringes by an anaesthetist or investigator who was not involved in subsequent patient care |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not reported, but outcomes probably recorded by staff involved in care |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No losses reported |
Selective reporting (reporting bias) | Low risk | Most expected outcomes reported |
Other bias | Low risk | None evident |