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NCT03040024 · ClinicalTrials.gov registry record · Phase 4
Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients
A Phase 4 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 71
- Enrollment target
NCT03040024: Clinical Trial Phase 4 study, sponsored by Emory University.
NCT03040024 is a Phase 4 study that was terminated before completion, run by Emory University. The registered enrollment target is 71 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03040024, a Phase 4 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 71 participants
- Enrollment target
Study Summary
The goal of this prospective randomized double blinded placebo controlled study is to investigate if a single dose of ketamine in addition to standard anesthesia will reduce the risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on post-operative pain and opioid use will be measured as well. Electroencephalogram (EEG) will be utilized during the surgical procedure to evaluate its potential as a possible predictive device for delirium.
Primary Outcome
The CAM-ICU assesses four features: 1) acute change or fluctuation in mental status from baseline, 2) inattention, 3) altered level of consciousness, and 4) disorganized thinking. The measure reports whether a participant meets criteria for delirium by summing the number of features answered as "present". Feature 1 plus 2 and either 3 or 4 present = delirium positive. Results are expressed as number of participants with or without delirium at each time frame.
Interventions
- DRUG Placebo
- DRUG Ketamine
- DEVICE Electroencephalogram (EEG)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 71 participants |
| Start Date | 2017-03-17 |
| Est. Completion | 2020-04-24 |
| Phase | Phase 4 |
Why NCT03040024 stopped before completion
NCT03040024 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 71 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT03040024 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03040024 about?
NCT03040024 is a clinical study titled "Delirium Prevention With Ketamine in Ear, Nose, and Throat (ENT) Patients". The goal of this prospective randomized double blinded placebo controlled study is to investigate if a single dose of ketamine in addition to standard anesthesia will reduce the risk of delirium in otolaryngeal cancer patients postoperatively. Ketamine's effect on post-operative pain and opioid use ...
What is the current status of trial NCT03040024?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 71 participants. The study started on 2017-03-17. Estimated completion is 2020-04-24.
What interventions are being tested in trial NCT03040024?
The interventions under investigation include: Placebo (DRUG), Ketamine (DRUG), Electroencephalogram (EEG) (DEVICE).
Who is sponsoring clinical trial NCT03040024?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03040024's enrollment target sits among peer trials
71 1040th of 2000 higher than 958 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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