Effect of Regional vs General Anesthesia on Incidence of Postoperative Delirium in Older Patients Undergoing Hip Fracture Surgery: The RAGA Randomized Trial.
Level 2 - randomized trial
Individual randomized controlled trial with allocation concealment
PubMed 34928310 · doi:10.1001/jama.2021.22647
What was done
A randomized, allocation-concealed, open-label trial was conducted across 9 university teaching hospitals in Southeastern China among 950 patients aged 65 years and older undergoing surgical repair for fragility hip fracture. Patients were randomized to receive either regional anesthesia without sedation (spinal, epidural, or combined; n = 476) or general anesthesia (intravenous, inhalational, or combined agents; n = 474). The primary outcome was the incidence of delirium during the first 7 postoperative days. Secondary outcomes included delirium severity, duration, subtype, pain scores, length of hospital stay, 30-day all-cause mortality, and adverse events.
What was found
Of 950 randomized patients, 941 were evaluable for the primary outcome. Postoperative delirium occurred in 29 patients (6.2%) in the regional anesthesia group versus 24 (5.1%) in the general anesthesia group (unadjusted risk difference [RD], 1.1%; 95% CI, -1.7% to 3.8%; P = .48; unadjusted relative risk [RR], 1.2; 95% CI, 0.7 to 2.0; P = .57). Mean delirium severity score was 23.0 vs 24.1 (unadjusted difference, -1.1; 95% CI, -4.6 to 3.1). Median worst pain score (0 vs 0) and median length of hospitalization (7 days vs 7 days) were identical between groups. All-cause 30-day mortality was 8 (1.7%) vs 4 (0.9%) (unadjusted RD, -0.8%; 95% CI, -2.2% to 0.7%; RR, 2.0; 95% CI, 0.6 to 6.5). Adverse event episodes totaled 106 in the regional group and 102 in the general group.
Why it matters
Contrary to the common clinical hypothesis that avoiding general anesthesia reduces cognitive complications, regional anesthesia without sedation does not lower the risk of postoperative delirium in older hip fracture surgery patients.
Limits
The trial was open-label, introducing potential detection bias. Delirium incidence was low (5.1% to 6.2%) compared with typical historical cohorts, which may limit statistical power to detect small differences or differences in rare delirium subtypes. The protocol strictly avoided sedation in the regional anesthesia arm, which may not reflect real-world clinical practice where sedation is frequently added. All participating centers were located in Southeastern China, potentially limiting geographic generalizability.
Cited by
- supports In the RAGA study of 950 hip fracture patients aged 65 and older, 6.2% of the regional group (29 out of 471) experienced delirium in the first week, compared to 24 patients in the general anesthesia group.