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

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
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.
Outcomes Maternal: hypotension, nausea and vomiting, incidence of vasopressor and dose of vasopressor used
Neonatal: Apgar scores
Notes Hypotension defined as decrease in SBP > 20% of baseline or SBP < 90 mmHg.
Bradycardia defined as heart rate < 50 bpm.
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