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Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Primary Purpose

Emergence Delirium, Anesthesia Emergence Delirium

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Monochromatic blue light
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Delirium focused on measuring Delirium, anesthesia, pediatrics

Eligibility Criteria

2 Years - 6 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • American Society of Anesthesiologist Classification of 1,2
  • Patients ages 2-6 years
  • Routine tonsillectomy and adenoidectomy

Exclusion Criteria:

American Society of Anesthesiology classification other than 1,2; history of migraine headaches; ocular disorders; seizure history; psychiatric conditions; anxiety; parental refusal; developmental delay; patients on medication for attention deficit disorders or caffeine stimulants; Patients with contraindications to receiving inhalation agents; Use of premedication with midazolam or dexmedetomidine;

Sites / Locations

  • Texas childrens Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

Blue light - non monochromatic

Monochromatic blue light

Arm Description

Outcomes

Primary Outcome Measures

Identify if monochromatic light reduces subjective incidence of emergence delirium
Assessment if monochromatic light reduces incidence of emergence delirium

Secondary Outcome Measures

Calculate the percent reduction in PAED scores in patients exposed to monochromatic light
Assessment of Pediatric Emergence Delirium Scale (PAED) scores at varying points during the initial recovery phase in patients exposure to monochromatic light vs. sham

Full Information

First Posted
September 13, 2017
Last Updated
March 4, 2021
Sponsor
Baylor College of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03285243
Brief Title
Effect of Monochromatic Light on Incidence of Emergence Delirium in Children
Official Title
Effect of Monochromatic Light on Incidence of Emergence Delirium in Children
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2017 (Actual)
Primary Completion Date
April 30, 2020 (Actual)
Study Completion Date
April 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed Description
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. Involuntary activity in the bed and even thrashing about during an episode of ED can lead to dislodgement of IV cannulas, surgical dressings and or surgically placed items such as drains and catheters. 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). Electroencephalograms (EEG) in patients experiencing emergence delirium show diffuse background slowing. 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. Monochromatic light (ML) has been used in a variety of clinical and non-clinical applications to affect a variety of changes. Exposure to light of short wavelength within the visible spectrum (450-470nm) has been associated with effects on circadian rhythm, neuroendocrine and neurobehavioral changes and enhanced cognitive performance. Blue ML has been studied safely to enhance work-place alertness and productivity. Clinically, blue ML has been used safely for decades in the neonatal intensive care unit to treat jaundice. Blue ML, has been known to suppress melatonin secretion and enhance alertness and workplace performance. The effect occurs within the retinal photoreceptive ganglion cells which mediate the observed responses. The effect is even present in visually blind persons lacking outer retinal function. Short exposure to bursts of blue light has revealed enhanced neural activity on functional MRI. Use of blue ML has been shown to enhance EEG activity in the alpha range (awake range) compared with light of greater wavelengths. Using blue ML in the operating room may enhance alpha EEG activity, (a circadian marker for alertness) it may be possible to reduce the incidence of emergence delirium in the post-operative period and therefore the amount of (non-pain) sedative medication needed in recovery.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Delirium, Anesthesia Emergence Delirium
Keywords
Delirium, anesthesia, pediatrics

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This is a double blinded randomized control trial. The placebo arm will serve as the control group. After enrollment and consent, each patient will be randomized to either placebo or intervention group. 110 sealed envelopes randomizing patients to the exposure group A (monochromatic light) or bulb B (placebo) white light bulb with blue outer coating.
Masking
ParticipantCare Provider
Masking Description
After enrollment and consent, each patient will be randomized to either placebo or intervention group. 110 sealed envelopes randomizing patients to the exposure group A (monochromatic light) or bulb B (placebo) white light bulb with blue outer coating. The recover room nursing staff will evaluate the patient using the PAED standard emergence delirium scale unaware of which light is monochromatic.
Allocation
Randomized
Enrollment
105 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blue light - non monochromatic
Arm Type
Sham Comparator
Arm Title
Monochromatic blue light
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Monochromatic blue light
Intervention Description
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
Primary Outcome Measure Information:
Title
Identify if monochromatic light reduces subjective incidence of emergence delirium
Description
Assessment if monochromatic light reduces incidence of emergence delirium
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Calculate the percent reduction in PAED scores in patients exposed to monochromatic light
Description
Assessment of Pediatric Emergence Delirium Scale (PAED) scores at varying points during the initial recovery phase in patients exposure to monochromatic light vs. sham
Time Frame
30 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologist Classification of 1,2 Patients ages 2-6 years Routine tonsillectomy and adenoidectomy Exclusion Criteria: American Society of Anesthesiology classification other than 1,2; history of migraine headaches; ocular disorders; seizure history; psychiatric conditions; anxiety; parental refusal; developmental delay; patients on medication for attention deficit disorders or caffeine stimulants; Patients with contraindications to receiving inhalation agents; Use of premedication with midazolam or dexmedetomidine;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam Adler, MD
Organizational Affiliation
Baylor College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Texas childrens Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Patient Data will be kept on file and disclosed at discretion of the PI in accordance with Baylor College of Medicine regulations
Citations:
PubMed Identifier
34496743
Citation
Adler AC, Nathanson BH, Chandrakantan A. Monochromic light reduces emergence delirium in children undergoing adenotonsillectomy; a double-blind randomized observational study. BMC Anesthesiol. 2021 Sep 8;21(1):217. doi: 10.1186/s12871-021-01435-1.
Results Reference
derived

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Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

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