Berggren 1987.
Methods | Design: Randomised trial of epidural and general anaesthesia in patients operated on for fracture neck of femur Date of study: March 1983 to November 1984 Power calculation: No Frequency of outcomes assessment: First and seventh day postoperatively Inclusion criteria: All fully lucid, consenting patients admitted to an orthopaedic unit for fracture neck of femur Exclusion criteria: Score more than 6/36 on 12 item disorientation sub‐scale of Organic Brain Syndrome (OBS) assessed within 3 hours of admission |
|
Participants | Number in study: 57 Country: Sweden Setting: Orthopaedic ward of one university hospital Age mean years (SD): Epidural 78(8), General 77(7) Sex M:F: Epidural 4/24, General 7/22 Co‐morbidity: No significant differences between groups (Chi2 test) for ischaemic heart disease, hypertension, diabetes mellitus, cerebrovascular disease, respiratory disease, depression, parkinsonism or sensory impairment Dementia: Not mentioned specifically but would in effect be excluded by exclusion criteria |
|
Interventions | Intervention: Epidural anaesthesia Comparison: Halothane anaesthesia | |
Outcomes | 1. Incident delirium measured using a modified version of the Organic Brain Syndrome Scale on postoperative days 1 and 7 2. Length of admission (data not fully reported) 3. Physical morbidity (stroke, urinary tract infection) 4. Psychological morbidity (depression) 5. Pressure ulcers |
|
Notes | Funding source: Swedish Medical Council; King Gustav V Birthday Foundation; Umea University Research Foundation Declarations of interest: Not reported Delirium not excluded at enrolment No data presented for length of admission but reported as no difference between the two groups |
|
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment (selection bias) | Unclear risk | Allocation concealment method not described |
Random sequence generation (selection bias) | Unclear risk | Method for random sequence generation not described |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Participants and personnel not blinded |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Assessors did not know allocation of participants at time of testing for delirium |
Incomplete outcome data (attrition bias) All outcomes | Low risk | All participants included in outcome reporting |
Selective reporting (reporting bias) | High risk | Reported outcomes which were not pre‐specified in the methods |
Other bias | Low risk | No evidence of other bias |