Papaioannou 2005.
| Methods | Design: Randomised trial of regional and general anaesthesia in elective surgery patients Date of study: Study dates not reported Power calculation: Yes Frequency of outcomes assessment: daily for first three postoperative days Inclusion criteria: Patients aged 60 years or over scheduled for elective surgery that could be performed under regional or general anaesthesia and who had agreed to be randomly allocated to receive either type of anaesthesia Exclusion criteria: Illiteracy, severe auditory or visual disturbances, central nervous system disorders, alcohol or drug dependence, treatment with tranquillisers or antidepressants, Parkinson's disease, and preoperative MMSE score less than 23 (indicative of dementia). |
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| Participants | Number in study: 50 Country: Greece Setting: Unclear Age 60‐69/70 and over: Regional 14/5, General 15/13 Sex M/F: Regional 12/7, General 18/10 Co‐morbidity: Not reported ASA score: ASA I‐II/II‐IV: Regional 16/3, General 27/1 Dementia: Excluded |
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| Interventions | Intervention: Regional anaesthesia (epidural or spinal) Control: General anaesthesia via propofol infusion or inhaled anaesthetic Both given to achieve a Ramsay sedation score of ≤2. Benzodiazepines not administered for premedication or intraoperative sedation. |
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| Outcomes | 1. Incident delirium using DSM‐III criteria with informant history from attending relatives and nurses. Unclear whether patients interviewed 2. Length of admission 3. Cognitive status using MMSE 4. Postoperative complications |
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| Notes | Funding source: European Commission BIOMED2 program BMH4‐98‐3335 and Greek Ministry of Health Declarations of interest: Not reported Delirium diagnosed using informant history from attending relatives and nurses. Unclear whether patients interviewed. Delirium not excluded at enrolment |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Allocation concealment (selection bias) | Low risk | Allocation concealed by central |
| Random sequence generation (selection bias) | Low risk | Computer programme used |
| Blinding of participants and personnel (performance bias) All outcomes | High risk | Unable to blind due to nature of intervention |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Method of outcome assessment is unclear, "incidence of delirium was evaluated by asking the attending nurses and relatives for features fulfilling the DSM III criteria" |
| Incomplete outcome data (attrition bias) All outcomes | High risk | 50 patients randomised, 4 randomised to intervention crossed‐over to general anaesthesia. Delirium incidence results presented are per protocol, intention‐to‐treat not reported in original paper |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to assess |
| Other bias | High risk | Potential confounding from unbalanced neuraxial analgesia use 18 in regional anaesthesia, 3 in general anaesthesia group |