Wang 2014b.
Study characteristics | ||
Methods | RCT | |
Participants | 66 women Inclusion criteria: primiparous, singleton pregnancy, elective caesarean, age 18‐35, 37‐42 weeks' gestation, ASA I‐II, normal prenatal examinations, normal renal and liver function, no medical history of heart or lung disease, no fetal abnormalities Exclusion criteria: hypertension, cardiovascular or cerebrovascular disease, placenta praevia, abnormal fetal development, contraindications to spinal anaesthesia, endocrine disorders, recent administration of 5‐HT reuptake inhibitors or drugs for treatment of migraines Setting: China |
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Interventions |
Prophylactic ondansetron versus control 5 min prior to spinal anaesthesia: Group 1: 4 mg IV ondansetron (diluted to 5 mL with physiological saline) Group 2: 5 mL IV physiological saline All women received the same standardised monitoring, cannulation, spinal anaesthetic technique and dose, standardised crystalloid coload and postdelivery oxytocin If hypotension occurred, 100 μg IV phenylephrine was administered, and repeated every 2 min as required until SBP > 80% baseline If bradycardia occurred, 0.5 mg IV atropine was administered If SpO2 < 95%, mask assisted O2 inhalation was given at 3 L/min If nausea or vomiting occurred, 12.5 mg IV promethazine was administered If intractable pain, assisted anaesthetics were added or GA performed and patient was excluded |
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Outcomes |
Maternal: incidence of hypotension, bradycardia, nausea and vomiting, peak block height, total consumption of phenylephrine Neonatal: umbilical cord gases, Apgar scores at 1 min and 5 min |
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Notes | Hypotension was defined as maternal SBP < 80% baseline Bradycardia was defined as heart rate < 50 bpm Hypertension was defined as SBP > 140 mmHg or DBP > 90 mmHg |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated |
Allocation concealment (selection bias) | Low risk | Opaque, sealed, sequentially numbered envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Study drugs prepared by anaesthetist not directly involved in the patient scare or assessment. Solutions were in syringes of similar appearance, labelled study drug |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above, anaesthetist was blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Group 1: 1 woman excluded from BP analysis due to intractable shivering preventing BP measurement, 2 women excluded from blood gas analysis due to insufficient samples Group 2: 1 woman completely excluded due to failed spinal anaesthesia, 2 women excluded from blood gas analysis because of insufficient samples |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent. Grant from Wuxi Municipal Health Bureau |