Bredahl 1991.
Methods | Randomized trial: method not stated Approved by the Ethics Committee and informed consent obtained from each patient |
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Participants | Orthopaedic hospital Aalborg, Denmark
30 ASA I or II physical status women with a proximal femoral fracture
Mean age 79 years (range 60‐90)
Male: 0%
Loss to follow‐up: not stated, but 2 excluded due to incomplete data Operated within 24 hours |
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Interventions |
Treatment group: Ephedrine 25 mg IM plus IV ephedrine for pre‐spinal hypotension (2 patients). Spinal anaesthesia at L2‐3 or L3‐4 with 2.5‐3 mL of 0.5% plain bupivacaine in lateral decubitus. Oxygen supplement during the surgical intervention, sedation with IV diazepam (n = 15)
Control group: General anaesthesia using thiopentone, pethidine, pancuronium, nitrous oxide/oxygen, IPPV, and suxamethonium (n = 15 randomized; 13 analysed) Premedication with pethidine 0.5 mg/kg for all patients. IM Nicomorphine for postoperative analgesia |
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Outcomes | Length of surgery | |
Notes | Study designed to examine the difference in body temperature between the two anaesthetic technique Length of follow‐up: 3 days Presence/absence of thromboprophylaxis not mentioned |
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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 | Two patients excluded from the general anaesthesia group for incomplete data |
Selective reporting (reporting bias) | Low risk | No failed spinal mentioned |
Other bias | Low risk | Groups well balanced |