Marciniak 2015.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 72 women Inclusion criteria: ASA I/II, elective CS due to cephalopelvic disproportion, post‐C‐section condition, gluteal position, ophthalmic indications and those without medical indications Exclusion criteria: lack of consent, contraindications to spinal anaesthesia, multiple pregnancy, body weight > 155 kg, height < 152 cm, age < 18 years or > 40 years, diabetes mellitus, pregnancy‐induced hypertension, chronic hypertension, cardiac diseases, use of selective serotonin reuptake inhibitors Setting: Poland |
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| Interventions |
Ondansetron versus control Group 1 (O): 8 mg ondansetron in 10 mL 0.9% NaCl IV Group 2 (P): 10 mL 0.9% NaCl IV Syringe content administered over 1 min, after colloid preload and 5 min prior to spinal anaesthesia. All women received standardised aspiration prophylaxis, standardised monitoring, standardised cannulation and colloid prehydration, standardised spinal anaesthetic technique and dose. Hypotension was managed with fractionated IV ephedrine boluses. Bradycardia was managed with 0.5 mg atropine. |
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| Outcomes |
Maternal: hypotension, bradycardia Neonatal: Apgar scores at 1 min and 5 min, baby's weight, umbilical vein acid‐base status |
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| Notes | Hypotension was defined as a 20% decrease in systolic pressure or decrease in systolic pressure < 90 mmHg 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 | Online randomisation programme |
| Allocation concealment (selection bias) | Low risk | Study drug prepared by anaesthetist otherwise uninvolved in study |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | The anaesthetist preparing the solution was on call, and the anaesthetist administering the solution was blinded. |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | 2 patients in placebo group received IV opioids due to insufficient analgesia and were thus excluded from the study |
| Selective reporting (reporting bias) | Low risk | Most expected outcomes were reported |
| Other bias | Low risk | None evident |