Davis 1987.
Methods | RCT Approved by the five Ethics Committee of the participating hospitals |
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Participants | Orthopaedic hospitals in New Zealand ‐ multicentre study
549 (538 analysed) participants with a proximal femoral fracture
Mean age 79.5 years (range not stated)
Male: 22%
Number lost to follow‐up: 0, but 11 excluded 20% subcapital and 80% trochanteric fractures Excluded if < 55 years of age, arthroplasty required, pathological fracture or contraindication to one anaesthetic technique |
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Interventions | Treatment group: Spinal anaesthesia with sedation with diazepam. Hyper of isobaric tetracaine, nupercaine or bupivacaine for spinal (n= 259 analysed) Control group: General anaesthesia with pre‐oxygenation, IV induction with thiopentone, IPPV maintained with nitrous oxide/oxygen, non‐depolarizing neuromuscular blocker, fentanyl (n = 279 analysed) | |
Outcomes | Mortality at 1 month (28 days) Operative hypotension requiring vasopressor Length of hospital stay | |
Notes | There was 1 non fatal anaphylactoid reaction at induction of general anaesthesia Length of follow‐up: 1 month A longer duration of follow‐up was available for a fraction of the patients only and therefore was not reported to decrease the chances of selective reporting |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Randomized with stratification by sex and hospital |
Allocation concealment (selection bias) | Unclear risk | Not mentioned |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Not mentioned |
Blinding of outcome assessment (detection bias) All outcomes | High risk | Not mentioned |
Incomplete outcome data (attrition bias) All outcomes | Low risk | 11 excluded out of 549. Exclusion were made on pre‐defined criteria: age less than 55 years, multiple trauma, possible replacement or hemi‐arthroplasty or pathological fractures |
Selective reporting (reporting bias) | Low risk | 30 failed spinal and 14 incomplete |
Other bias | Low risk | Groups well balanced. Intention‐to‐treat |