Sahoo 2012.
Study characteristics | ||
Methods | RCT | |
Participants | 56 women Inclusion criteria: ASA I, age 20‐40, elective LSCS Exclusion criteria: contraindications to SAB, patient refusal, unstable haemodynamics, coagulopathy, history of hypersensitivity to ondansetron or local anaesthetic agents, hypertensive disorders of pregnancy, cardiovascular insufficiency, receiving selective serotonin reuptake inhibitors or migraine medications Setting: India |
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Interventions |
Pretreatment with ondansetron versus placebo Group 1: IV ondansetron 4 mg diluted in 10 mL of normal saline given over 1 min, 5 min before spinal anaesthesia Group 2: 10 mL of normal saline IV given over 1 min, 5 min before spinal anaesthesia |
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Outcomes |
Maternal: hypotension, decrease in BP, decrease in heart rate, nausea and vomiting Neonatal: none |
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Notes | Hypotension: SBP < 90 mmHg or DBP < 60 mmHg Bradycardia: 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 chart |
Allocation concealment (selection bias) | Unclear risk | Not reported |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not reported |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded anaesthetist assessing outcomes |
Incomplete outcome data (attrition bias) All outcomes | Low risk | Not apparent |
Selective reporting (reporting bias) | Low risk | Not apparent |
Other bias | Low risk | Not apparent |