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. 2020 Jul 1;2020(7):CD002251. doi: 10.1002/14651858.CD002251.pub4

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
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
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
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
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