Eldaba 2015.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 200 women Inclusion criteria: ASA I/II, aged 18‐30 years, elective CS Exclusion criteria: patient refusal, contraindication to spinal anaesthesia, known allergy to granisetron, patients receiving serotonin agonists or antagonists, ischaemic heart disease, chronic hypertension or pregnancy‐induced hypertension Setting: Egypt |
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| Interventions |
Granisetron versus control Group 1: 1 mg granisetron diluted in 10 mL normal saline IV administered slowly over 1 min, 5 min prior to spinal anaesthesia Group 2: 10 mL normal saline IV administered slowly over 1 min, 5 min prior to spinal anaesthesia (placebo) All women received a crystalloid preload (500 mL Ringer's lactate), standardised positioning, standardised spinal anaesthetic technique and dose, standardised maintenance IVT. Hypotension was managed with a rapid bolus of 100 mL of Ringer's lactate. Vasopressors administered if MABP < 70 mmHg: ephedrine 5 mg IV bolus if heart rate was < 90 bpm, phenylephrine 0.1 mg IV bolus if heart rate > 90 bpm. Bradycardia (if not associated with hypotension) was treated with 0.5 mg atropine. |
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| Outcomes |
Maternal: incidence of hypotension, heart rate Neonatal: Apgar scores at 1 min and 5 min |
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| Notes | Hypotension was defined as MAP < 70 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‐based randomisation |
| Allocation concealment (selection bias) | Unclear risk | Assignment in sealed envelopes |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Double‐blinded. Syringed were prepared by an anaesthetist who was blinded to the study protocol |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | As above |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 5 excluded (3 from group 1 and 2 from group 2) due to conversion to GA No statement with respect to 'intention‐to‐treat' |
| Selective reporting (reporting bias) | Low risk | Most expected outcomes reported |
| Other bias | Low risk | None evident |