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 |
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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 |
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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 |
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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 |