Effect of combination of multiple anti-inflammatory drugs strategy on postoperative delirium among older patients undergoing hip fracture surgery: a pilot randomized controlled trial
Abstract
Postoperative delirium is the most common complication in older patients and is associated with surgery-induced inflammation. Although inflammation plays a key role in delirium, the potential benefits of a comprehensive anti-inflammatory approach to managing perioperative systemic inflammation remain underexplored. This study evaluated whether a perioperative anti-inflammatory bundle strategy, combining dexmedetomidine, glucocorticoids, ulinastatin, and nonsteroidal anti-inflammatory drugs, reduces the risk of postoperative delirium in older patients undergoing hip fracture surgery. This dual-center, double-blind, placebo-controlled, parallel-group, pilot study was conducted from August 2023 to January 2024 at two tertiary university hospitals. A total of 132 patients aged ≥ 65 years with an American Society of Anesthesiologists physical status of 2 or 3 scheduled for elective hip fracture surgery were screened and randomized to receive either an anti-inflammatory drug bundle or a placebo. The primary outcome was postoperative delirium, identified within the first three postoperative days. Postoperative blood inflammatory markers and acute pain were measured for mediation analysis. Of the 132 patients randomized, 123 (93%) completed the trial (mean age, 82 years; 75% women). The prevalence of postoperative delirium was significantly lower in the anti-inflammatory bundle group (15%, 9/62) compared to the placebo group (44%, 27/61) (risk difference, − 30 percentage points [95%…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 132 participants or records.
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