drugset / Trial / NCT02109081

Dexamethasone and Postoperative Delirium

NCT02109081 ↗

Phase 4 Terminated 200 enrolled Endeavor Health
RandomizedParallel-groupQuadruple-blindPrevention

Summary

Postoperative delirium is commonly observed in elderly patients in the postanesthesia care unit (PACU) and during the first 2-3 days following surgical procedures. This is an important clinical problem in the geriatric surgical patient; morbidity and mortality rates are significantly higher in patients who develop delirium. At the present time, the etiology of delirium has not been precisely defined. However, studies suggest that inflammation related to the surgical stress response is an important contributing factor in inducing neuroinflammation and subsequent cognitive dysfunction and delirium. Therefore it is possible that agents which attenuate perioperative inflammation may reduce the risk of the development of delirium following surgery. Dexamethasone is a potent corticosteroid that is used by anesthesiologists primarily as an antiemetic agent. Small doses of dexamethasone have also been demonstrated to significantly reduce the release of inflammatory markers after surgery. The anti-inflammatory effects of corticosteroids have the potential to beneficially impact neuroinflammation and the risk of developing postoperative delirium. The aim of this randomized, controlled, double-blinded investigation is to determine if dexamethasone, administered at induction of anesthesia, can decrease the incidence of delirium at the time of discharge from the PACU and during the first 2 days following surgery.

Timeline

Start
2014-04
Primary completion
2021-02
Completion
2021-02

Outcome

Outcome not reported

Stopped: “Investigator left institution”

Drugs

EvaluationDrugModalityDoseRoute
Subject Dexamethasone Small molecule 10 mg —