Gulhas 2012.
| Study characteristics | ||
| Methods | RCT | |
| Participants | 105 women Inclusion criteria: ASA I‐II, aged 18‐45 years, elective CS under SAB Exclusion criteria: contraindication to regional anaesthesia, ASA score III‐IV, < 18 years of age, multiple gestation, < 150 cm tall or > 170 cm tall, pre‐eclampsia, eclampsia, diabetes mellitus, intrauterine anomalities, using medications containing ephedrine or phenylephrine, failed SAB requiring conversion to general anaesthesia Setting: Turkey |
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| Interventions |
Various doses of ketamine versus control Group 1: 0.25 mg/kg IV ketamine administered immediately following intrathecal injection Group 2: 0.5 mg/kg IV ketamine administered immediately following intrathecal injection Group 3: placebo control: 2 mL physiological saline administered immediately following intrathecal injection All women received a standardised crystalloid preload, a standardised spinal anaesthetic technique and dose), standardised monitoring and standardised surgical positioning. Hypotension was managed with 10 mg ephedrine IV. Atropine was administered if heart rate was < 45 bpm. |
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| Outcomes |
Maternal: hypotension, ephedrine use, sedation score, shivering, pruritus, nausea and vomiting, hallucinations Neonatal: Apgars, cord blood pH |
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| Notes | Hypotension defined as > 20% reduction in SBP from baseline | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | Computer‐generated numbers (Excel) by anaesthetist not involved in study |
| Allocation concealment (selection bias) | Unclear risk | Not reported |
| Blinding of participants and personnel (performance bias) All outcomes | Low risk | Blinded outcome data assessors and "ward staff" |
| Blinding of outcome assessment (detection bias) All outcomes | Low risk | Blinded outcome data assessors and "ward staff" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 3 patients excluded with failed blocks, flow diagram does not actually make sense from protocol as patients would have received placebo/Ketamine before exclusion |
| Selective reporting (reporting bias) | Low risk | None apparent |
| Other bias | Low risk | None apparent |