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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: Clinical Trial Phase 4 study, sponsored by Endeavor Health.

NCT02109081 is a Phase 4 study that was terminated before completion, run by Endeavor Health. The registered enrollment target is 200 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

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.

Interventions

  • DRUG Placebo
  • DRUG Dexamethasone

Trial Details

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

94 total trials

Why NCT02109081 stopped before completion

NCT02109081 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (61% lower).

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

NCT02109081 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT02109081's enrollment target sits among peer trials

200 407th of 2000 higher than 1,556 of 2,000 other Phase 4 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT02109081, the US trial registry maintained by the National Library of Medicine. NCT02109081 (mid enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.