Doherty 2012.
Study characteristics | ||
Methods | RCT | |
Participants | 69 women Inclusion criteria: ASA physical status I/II; aged 18 years and older; weight 50‐100 kg; height between 150 and 180 cm Exclusion criteria: allergy or hypersensitivity to phenylephrine; hypertension; cardiovascular or cerebrovascular disease; fetal abnormalities; diabetes (excluding gestational diabetes); or contraindications to spinal anaesthesia Setting: Canada |
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Interventions |
Phenylephrine infusion versus phenylephrine bolus Group 1: infusion: fixed rate phenylephrine infusion 120 μg/min; infusion was started immediately on completion of intrathecal injection, at a rate of 1 mL/min and continued for a minimum of 2 min, and continued if maternal SBP was equal to or lower than baseline. If maternal BP was higher than baseline, the infusion was discontinued and the BP reassessed after 2 min Group 2: bolus: intermittent phenylephrine bolus of 120 μg; women received 1 mL of bolus solution every time SBP was equal to or lower than baseline. A bolus was not administered when SBP was above baseline All women received an IV infusion of Ringer's lactate started at a minimal rate in the holding area, with subsequent standardised crystalloid coload on administration of spinal anaesthetic. No antiemetic premedication was given. All women received a standardised spinal anaesthetic technique, dose and positioning. Hypotension requiring intervention received rescue dose of 5 mg ephedrine. Bradycardia requiring intervention received 0.6 mg atropine if heart rate < 60 bpm for 2 consecutive readings and SBP equal to or lower than baseline (infusion was discontinued if bradycardia with SBP higher than baseline). |
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Outcomes |
Maternal: BP; cardiac output; heart rate, hypotension; hypertension; nausea/vomiting; bradycardia; total dose of phenylephrine Neonatal: umbilical blood gases; neonatal weight; Apgar score at 1 min and 5 min |
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Notes | Hypotension was defined as SBP < 80% baseline. Hypertension was defined as SBP > 120% baseline. 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) | Low risk | Computer‐generated random number table |
Allocation concealment (selection bias) | Unclear risk | Sealed, opaque envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | "Double blind": women and attending anaesthetists were blinded to the group allocation. 2 syringes, 1 20 mL bolus and 60 mL infusion were prepared for each woman. 1 syringe contained 120 μ/mL phenylephrine and the second syringe contained saline. Both syringes were labelled 'phenylephrine/placebo' and 'bolus syringe' and 'infusion syringe' respectively. The anaesthetist then received 1 syringe of infusion solution and 1 syringe of bolus solution (but did not know which syringe contained the phenylephrine). Each was administered according to the protocol for bolus and infusion as described above. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Not specifically stated, but probably done |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 9/69 were lost to follow‐up: 4/35 from the intervention group (3 pump errors; 1 unable to calibrate properly) and 5/35 from the bolus group (2 required additional anaesthesia (ketamine), 2 pump errors and 1 unable to calibrate properly) |
Selective reporting (reporting bias) | Unclear risk | Most expected outcomes were reported, although blood gases reported only as mean and SD, and not specified if maternal hypertension required intervention |
Other bias | Low risk | Baseline characteristics were similar |