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

Ortiz‐Gomez 2014.

Study characteristics
Methods RCT
Participants 128 women
Inclusion criteria: ASA I, elective caesarean under spinal anaesthesia
Exclusion criteria: patient refusal to participate, contraindication to spinal anaesthesia, age < 20 or > 45 years, BMI > 30 kg/m², history of allergy or side effects to ondansetron
Setting: Spain
Interventions Comparison of different doses of prophylactic ondansetron with placebo
Group 1: placebo 0.9% saline 10 mL
Group 2: 2 mg ondansetron with 0.9% saline to total volume of 10 mL
Group 3: 4 mg ondansetron with 0.9% saline to total volume of 10 mL
Group 4: 8 mg ondansetron with 0.9% saline to total volume of 10 mL
The above 10 mL preparation was injected IV over 60 s, 5 min before the spinal anaesthesia was performed
All women received the same IV cannulation, monitoring, spinal anaesthetic technique with dose adjusted according to height, and 8 mL/kg of colloid coloading
Hypotension was treated with IV ephedrine 10 mg, or phenylephrine 50 μg if maternal heart rate > 95 beat/min
Bradycardia was treated with IV atropine 0.01 mg/kg
Outcomes Maternal: incidence of hypotension, adverse effects, need for atropine or ephedrine or phenylephrine
Notes Hypotension defined as SBP < 75% of baseline
Bradycardia was defined as heart rate < 45 beat/min
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Randomised by local statistical department
Allocation concealment (selection bias) Low risk Ondansetron/placebo syringes were prepared by the anaesthetic nurse with no label indicating the group allocation
Blinding of participants and personnel (performance bias)
All outcomes Low risk Double‐blinded
Blinding of outcome assessment (detection bias)
All outcomes Low risk Double‐blinded
Incomplete outcome data (attrition bias)
All outcomes Low risk None reported
Selective reporting (reporting bias) Low risk None apparent
Other bias Low risk None apparent