Dexamethasone and Postoperative Delirium

NCT02109081 | Terminated Phase 4

• 1 other identifier: EH13-477
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium; Postoperative Cognitive Dysfunction

Keywords

dexamethasone; delirium; postoperative cognitive dysfunction; postoperative; elderly

Outcome Measures

Primary Outcomes (1)

• Postoperative delirium at postanesthesia care unit (PACU) discharge

  The Confusion Assessment Method (CAM) test will be used to determine the presence or absence of delirium. The CAM assesses the acute onset and attention deficits as primary features, and level of consciousness and disorganized thinking as secondary features. In order to measure the primary and secondary components of the CAM, additional formal testing is required; the Mini Mental State Exam (MMSE) will be used.

  45 minutes after PACU admission

Secondary Outcomes (6)

• Postoperative delirium day one

  24 hours after surgery

• Postoperative delirium day two

  48 hours after surgery

• MMSE scores at postanesthesia care unit discharge

  45 minutes after PACU admission

• MMSE on postoperative day one

  24 hours after surgery

• MMSE on postoperative day two

  48 hours after surgery

Study Arms (2)

Dexamethasone

EXPERIMENTAL

Patients will be administered dexamethasone 10 mg at induction of anesthesia

Drug: Dexamethasone

Placebo-2.5 cc of saline

PLACEBO COMPARATOR

Patients will be administed placebo at induction of anesthesia

Drug: Placebo

Interventions

Dexamethasone DRUG

Dexamethasone

Placebo DRUG

Placebo-2.5 cc of saline

Eligibility Criteria

• Age: 70 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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.

Sponsors & Collaborators

• Endeavor Health: lead

Study Sites (1)

NorthShore University HealthSystem

Evanston, Illinois, 60201, United States

Location

MeSH Terms

Conditions

Delirium; Postoperative Cognitive Complications

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Postoperative Complications; Pathologic Processes; Cognitive Dysfunction; Cognition Disorders

Intervention Hierarchy (Ancestors)

Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated

Study Officials

• Glenn S. Murphy, MD

  Endeavor Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2014
• First Posted: April 9, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: December 21, 2021

Record last verified: 2019-09

Locations

US (1)