CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
Monochromatic blue lightdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03285243
NCT03285243N/ACompleted

Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Baylor College of Medicine·interventional·Posted Sep 15, 2017·Updated Feb 29, 2024

In Brief

A clinical study evaluating Monochromatic blue light for Emergence Delirium and Anesthesia Emergence Delirium. Completed, enrolled 104 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedSep 15, 2017
Enrollment StartNov 3, 2017
Primary CompletionApr 30, 2020
Study CompletionJun 2, 2020
TodayJul 2, 2026
Enrollment to primary: 2.5 yearsPosted 8.8 years ago

Interventions

Monochromatic blue lightdevice

Exposure to monochromatic light for the first 30 minutes in the recovery period after anesthesia to assess incidence of emergence delirium as noted by the PAED scale