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NCT03285243 · ClinicalTrials.gov registry record · NA
Effect of Monochromatic Light on Incidence of Emergence Delirium in Children
A NA study of Emergence Delirium and Anesthesia Emergence Delirium, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- NA
- Development phase
- 104
- Enrollment target
- 1
- Study location
NCT03285243: Completed NA study of Emergence Delirium and Anesthesia Emergence Delirium, sponsored by Baylor College of Medicine.
NCT03285243 is a NA study of Emergence Delirium and Anesthesia Emergence Delirium that has completed, run by Baylor College of Medicine. The registered enrollment target is 104 participants, below the 115-participant average among 3 other Emergence Delirium trials with a reported enrollment target (10% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03285243, a NA study of Emergence Delirium and Anesthesia Emergence Delirium, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- NA
- Development phase
- 104 participants
- Enrollment target
- 1
- Study location
Study Summary
Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology consisting of short lived behavioral changes that can be both traumatic to families and pose a safety risk to patients and staff. ED is characterized by a variety of presentations, including crying, excitation and agitation, that occur during the early stage of recovery from general anesthesia, generally in the first 30 minutes. Emergence delirium occurs in children of all ages following an anesthetic with halogenated agents (e.g. sevoflurane/isoflurane) with or without having undergone a surgical procedure (e.g. MRI patients). Presently, the treatment for ED is to revert the patient back to a hypnotic state mainly with sedatives so that they may "reset" themselves postulating that by re-inducing a hypnotic state, the brain has time to resolve this issue. The hypothesis of this study is that during ED, there is failure of organized EEG activity, especially alpha wave activity and that by enhancing alpha activity, the incidence of ED may be reduced without the need for additional pharmaceuticals which may be costly, delay recovery and are not without adverse effects specifically cardiopulmonary depression through the use of blue monochromatic light.
Primary Outcome
Assessment if monochromatic light reduces the absolute incidence of emergence delirium following general anesthesia (as a binary: emergence delirium vs. no emergence delirium)
Conditions Studied
Interventions
- DEVICE Monochromatic blue light
Study Locations (1)
Texas
- Texas childrens Hospital - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 104 participants |
| Start Date | 2017-11-03 |
| Est. Completion | 2020-06-02 |
| Phase | NA |
What the finished NCT03285243 record still lists
NCT03285243 is an interventional study that assigns participants to a tested intervention. The registered 104 participants enrollment target is mid-sized for trials with a published cap, below the 115-participant average among 3 other Emergence Delirium trials with a reported enrollment target (10% lower).
The record links to 2 conditions, with Emergence Delirium appearing as the primary indexed condition, and to 1 intervention - of which Monochromatic blue light is the first listed.
NCT03285243 reports a single indexed study location in Texas.
Frequently Asked Questions
What is clinical trial NCT03285243 about?
NCT03285243 is a clinical study titled "Effect of Monochromatic Light on Incidence of Emergence Delirium in Children". Emergence delirium/emergence agitation (ED/EA) is a behavioral phenomenon of unclear etiology consisting of short lived behavioral changes that can be both traumatic to families and pose a safety risk to patients and staff. ED is characterized by a variety of presentations, including crying, excitat...
What is the current status of trial NCT03285243?
This trial is currently completed. It is a NA study. The enrollment target is 104 participants. The study started on 2017-11-03. Estimated completion is 2020-06-02.
What conditions does trial NCT03285243 study?
This clinical trial studies the following conditions: Emergence Delirium, Anesthesia Emergence Delirium.
What interventions are being tested in trial NCT03285243?
The interventions under investigation include: Monochromatic blue light (DEVICE).
Who is sponsoring clinical trial NCT03285243?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03285243 being conducted?
This trial has 1 study location across Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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