Skip to main content
. 2020 Jul 1;2020(7):CD002251. doi: 10.1002/14651858.CD002251.pub4

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
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.
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
Notes Definition of hypotension is a SBP measurement < 90 mmHg.
Bradycardia was defined as heart rate < 60 bpm.
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