Effect of Monochromatic Light on Incidence of Emergence Delirium in Children
Condition: Emergence Delirium; Anesthesia Emergence Delirium
MeSH terms: Delirium; Emergence Delirium
Study type: Interventional

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.
    

Intervention name(s): Monochromatic blue light
Intervention type(s): Device
Intervention description(s): 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
Allocation: Randomized
Intervention model: Single Group Assignment
Intervention 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 (Participant, Care Provider)
Primary purpose: Prevention
Keywords: Delirium, anesthesia, pediatrics