Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Conditions
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Emergence Delirium, Anesthesia Emergence Delirium

Intervention / Treatment
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* Device: Monochromatic blue light


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 6 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Blue light - non monochromatic<br> | Device: Monochromatic blue light<br>* 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<br>|
| Experimental: Monochromatic blue light<br> | Device: Monochromatic blue light<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify if monochromatic light reduces subjective incidence of emergence delirium | Assessment if monochromatic light reduces incidence of emergence delirium | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 30 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Delirium, anesthesia, pediatrics