McKenzie 1984.
Methods | Randomized trial: use of envelopes containing random numbers | |
Participants | Orthopaedic hospital in Glasgow, Scotland
150 patients with fractured neck of femur Nail/plate no hemiarthroplasty Mean age 75 years (range not stated) Male: % not stated Mean delay before the surgery 48 hours Number lost to follow‐up: 0, but 2 excluded due to postponement of operation |
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Interventions | Treatment group: Spinal anaesthesia with 0.5% hyperbaric cinchocaine 1.3‐1.5 mL at L3‐4 or L4‐5 . Supplemented by small doses of diazepam if required (n = 73) Control group: General anaesthesia induced with althesin 1‐3 mL, suxamethonium 50 mg, nitrous oxide and oxygen, halothane and spontaneous respiration (n = 75) | |
Outcomes | Mortality at 1, 3, 6 and 12 months Length of surgery Operative blood loss Length of hospital stay Deep vein thrombosis (venography; subgroup of 40) Returned home | |
Notes | Additional information supplied by Dr McLaren indicated that all the references referred to one study. Additional data on mortality supplied Length of follow‐up: 12 months The venography study for DVT detection involved a subgroup of 40 patients |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | " randomly allocated." No details |
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 | No loss to follow‐up. Over the period study, operation was postponed in only two patients (not included in the 150). In two patients, the subarachnoid space could not be identified and these patients received general anaesthesia and were excluded from the study. |
Selective reporting (reporting bias) | Low risk | The authors provided results for all measurements for 148 patients. |
Other bias | High risk | Groups well balanced. Not in intention‐to‐treat: two patients randomized, excluded (surgery postponed) |