Skip to main content
. 2020 Jul 1;2020(7):CD002251. doi: 10.1002/14651858.CD002251.pub4

Terkawi 2015.

Study characteristics
Methods RCT
Participants 91 women
Inclusion criteria: elective CS
Exclusion criteria: diabetes, chronic hypertension, gestational hypertension, pre‐eclampsia, cardiac disease, patients with long QT syndrome and known contraindications to spinal anaesthesia
Setting: USA
Interventions Ondansetron versus control
Group 1: received 8 mg ondansetron diluted in 10 mL in 0.9% NaCl
Group 2: received 10 mL of 0.9% NaCl
Study drug was administered over a period of 5 min whilst in sitting position, prior to SAB.
All women received standardised aspiration prophylaxis, standardised colloid preload, standardised crystalloid maintenance fluid, standardised monitoring, standardised spinal anaesthetic technique and dose, standardised positioning.
Hypotension was managed with boluses of 100 μg of phenylephrine administered incrementally until SBP > 90 mmHg.
Bradycardia was managed with 0.4 mg atropine or 0.2 mg glycopyrrolate.
Outcomes Maternal: incidence of hypotension, incidence of bradycardia, amount of vasopressor and anticholinergic agents given, pruritus, nausea and vomiting, extent of sensory block, estimated blood loss, total fluid administered
Neonatal: Apgar scores
Notes Hypotension was defined as SBP < 90 mmHg or 20% drop in SBP from baseline.
Bradycardia was defined as heart rate < 60 bpm.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Computer‐generated randomisation
Allocation concealment (selection bias) Unclear risk Not clear
Blinding of participants and personnel (performance bias)
All outcomes Low risk Drugs prepared by pharmacist
Blinding of outcome assessment (detection bias)
All outcomes Low risk All research personnel were blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk Group 1: 4 excluded (3 due to protocol violation, 1 due to failed SAB)
Group 2: 1 excluded (due to protocol violation)
Selective reporting (reporting bias) Low risk Not apparent
Other bias Low risk None evident