Dexamethasone and Postoperative Delirium

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: NorthShore University HealthSystem; NorthShore University HealthSystem Research Institute
• Treatments: BB 1101; Dexamethasone; Dexamethasone 21-phosphate; Dexamethasone acetate

Criteria

Inclusion Criteria:

• patients ≥ 70 years of age, undergoing a noncardiac surgical procedure under general anesthesia, with an anticipated duration of postoperative admission of at least 2 days.

Exclusion Criteria:

• 1) preoperative diagnosis of delirium or dementia; 2) MMSE score of ≤ 20 out of 30 on preoperative testing (more than mild cognitive impairment) or delirium on preoperative CAM testing; 3) language barriers that would preclude testing; 4) preoperative steroid use within 3 days of surgery; or 5) anticipation of postoperative intubation.