Wajima 1995.
| Methods | RCT Informed consent of this studies were obtained from the patients and families |
|
| Participants | Hospital in Higashine, Japan
41 (randomized) patients with a femoral neck fracture
Mean age 80 (range: inclusion criteria ages 70‐90 years)
Male: 22% Number lost to follow‐up: Probably none Operated with a mean delay of 7 and 10 days after the surgery |
|
| Interventions | Treatment group: Epidural anaesthesia with continuous infusion of bupivacaine and butorphanol for 72 hours postoperatively (n = 16; 8 between 70 and 80 years of age and 8 > 80 years of age) Control group: General anaesthesia with thiopental, succinylcholine, nitrous oxide and sevoflurane. Postoperative analgesia with diclofenac. (n = 25; 10 between 70 and 80 years of age and 15 > 80 years of age) | |
| Outcomes | Mental tests (Hasegawa dementia scale scores) at 7 days (a high score means good mental function). Not retained in the analysis | |
| Notes | In Japanese Length of follow‐up: 1 week The study contains participants with abdominal and hip fracture surgery (41 randomized and 9 not randomized) for a total of 98 participants. Results in tables are provided for 40 participants (19 for neuraxial blockade and 21 for general anaesthesia). These tables contain results for delirium after the surgery. A letter was sent to authors on January 27, 2016 to obtain number of participants with hip surgery who experienced acute confusional state within seven days. We did not receive any reply so far. |
|
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | High risk | "randomly allocated", no details and size of the groups unequal (16 versus 25) |
| 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 |
| Selective reporting (reporting bias) | Low risk | No failed epidural mentioned |
| Other bias | Unclear risk | Patients of the GA group in the 70s had higher preoperative scores while those in the 80s had lower ones |