Nivatpumin 2016.
Study characteristics | ||
Methods | RCT | |
Participants | 168 women Inclusion criteria: age > 18 years, ASA I‐II, term singleton pregnancy, elective caesarean delivery under spinal anaesthesia Exclusion criteria: diabetes mellitus other than gestational diabetes, hypertension, BMI > 40 kg/m², complicated pregnancy, allergy to study drugs, long QT syndrome, contraindications to spinal anaesthesia Setting: Thailand |
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Interventions |
Ondansetron versus ephedrine versus control Group 1: ephedrine 10 mg IV Group 2: ondansetron 8 mg IV Group 3: normal saline IV Above interventions were diluted in 10 mL 0.9% saline and administered immediately after spinal anaesthesia. All women received the same aspiration prophylaxis, monitoring, crystalloid preload, anaesthetic technique and dose. If hypotension developed, women received ephedrine 5‐10 mg or noradrenalin 4‐8 μg IV (choice of agent was up to the attending anaesthetist). Bradycardia was treated with IV atropine 0.6 mg. |
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Outcomes |
Maternal: hypotension, nausea and vomiting, incidence of vasopressor and dose of vasopressor used Neonatal: Apgar scores |
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Notes | Hypotension defined as decrease in SBP > 20% of baseline or SBP < 90 mmHg. Bradycardia defined as heart rate < 50 bpm. |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Computer‐generated randomisation table |
Allocation concealment (selection bias) | Low risk | Sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Only 2 women were excluded due to protocol violations |
Selective reporting (reporting bias) | Low risk | None apparent |
Other bias | Low risk | None apparent |