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Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

NCT03285243 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2024-02-29

Study results available
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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.

Conditions

  • Emergence Delirium
  • Anesthesia Emergence Delirium

Interventions

DEVICE

Monochromatic blue light

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

Sponsors & Collaborators

  • Baylor College of Medicine

    lead OTHER

Principal Investigators

  • Adam Adler, MD · Baylor College of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2020-04-30
Completion
2020-06-02
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03285243 on ClinicalTrials.gov