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NCT02109081 · ClinicalTrials.gov registry record · Phase 4

Dexamethasone and Postoperative Delirium

A Phase 4 study, sponsored by Endeavor Health.

Terminated
Registry status
Phase 4
Development phase
200
Enrollment target

NCT02109081 is a Phase 4 study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 200 participants.

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The verdict

NCT02109081, a Phase 4 study, was terminated before completion, sponsored by Endeavor Health.

TERMINATED
Registry status
Phase 4
Development phase
200 participants
Enrollment target

Study 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.

Interventions

  • DRUG Placebo
  • DRUG Dexamethasone

Trial Details

FieldValue
Enrollment Target 200 participants
Start Date 2014-04
Est. Completion 2021-02
Phase Phase 4

Sponsor

Endeavor Health

94 total trials

What the Registry Record Tells You About NCT02109081

The ClinicalTrials.gov registry entry for NCT02109081 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Endeavor Health, which has 94 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.

NCT02109081 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT02109081 about?

NCT02109081 is a clinical study titled "Dexamethasone and Postoperative Delirium". 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 patie...

What is the current status of trial NCT02109081?

This trial is currently terminated. It is a Phase 4 study. The enrollment target is 200 participants. The study started on 2014-04. Estimated completion is 2021-02.

What interventions are being tested in trial NCT02109081?

The interventions under investigation include: Placebo (DRUG), Dexamethasone (DRUG).

Who is sponsoring clinical trial NCT02109081?

This trial is sponsored by Endeavor Health, which has 94 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.