An interventional study of Monochromatic blue light in Emergence Delirium and Anesthesia Emergence Delirium, sponsored by Baylor College of Medicine. Completed at 1 site in United States. Open to participants aged 2 Years to 6 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-02-29.
Sponsored by Baylor College of Medicine · Not applicable, Interventional, and Treatment
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.
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.
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;
Device: Monochromatic blue light
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
Number of Participants With Emergence Delirium Following Anesthesia in Children
Assessment if monochromatic light reduces the absolute incidence of emergence delirium following general anesthesia (as a binary: emergence delirium vs. no emergence delirium)
Time frame: 30 minutes
Number of Participants With PAED Scale Score of 12 or More for 30 Minutes After Baseline
Assessment of Pediatric Emergence Delirium Scale (PAED) scale scores at varying points during the initial recovery phase in patients exposure to monochromatic light vs. sham Pediatric Emergence Delirium Scale scored ranges from a Minimum of 2 to a maximum of 20. Higher scores are associate with emergence delirium and agitation indicating a worse outcome
Time frame: 30 minutes
Recruitment was performed between November 3, 2017 and June 2, 2020
| Milestone | Blue Light - Non Monochromatic | Monochromatic Blue Light |
|---|---|---|
| Started | 52 | 52 |
| Completed | 52 | 51 |
| Not completed | 0 | 1 |
Assessment if monochromatic light reduces the absolute incidence of emergence delirium following general anesthesia (as a binary: emergence delirium vs. no emergence delirium)
| Participants | Blue Light - Non Monochromatic | Monochromatic Blue Light |
|---|---|---|
| Number of Participants With Emergence Delirium Following Anesthesia in Children | 17 | 3 |
Assessment of Pediatric Emergence Delirium Scale (PAED) scale scores at varying points during the initial recovery phase in patients exposure to monochromatic light vs. sham Pediatric Emergence Delirium Scale scored ranges from a Minimum of 2 to a maximum of 20. Higher scores are associate with emergence delirium and agitation indicating a worse outcome
| Participants | Blue Light - Non Monochromatic | Monochromatic Blue Light |
|---|---|---|
| Number of Participants With PAED Scale Score of 12 or More for 30 Minutes After Baseline | 27 | 12 |
Collected over 1 hour. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Blue Light - Non Monochromatic | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Monochromatic Blue Light | 0/52 (0%) | 0/52 (0%) | 0/52 (0%) |
| Age, Categorical(Participants) | Blue Light - Non Monochromatic | Monochromatic Blue Light | Total |
|---|---|---|---|
| <=18 years | 52 | 52 | 104 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Blue Light - Non Monochromatic | Monochromatic Blue Light | Total |
|---|---|---|---|
| Mean | 4.2 ± 1.4 | 4.7 ± 1.3 | 4.5 ± 1.4 |
| Sex: Female, Male(Participants) | Blue Light - Non Monochromatic | Monochromatic Blue Light | Total |
|---|---|---|---|
| Female | 24 | 24 | 48 |
| Male | 28 | 28 | 56 |
| Race (NIH/OMB)(Participants) | Blue Light - Non Monochromatic | Monochromatic Blue Light | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 52 | 52 | 104 |
| Region of Enrollment(participants) | Blue Light - Non Monochromatic | Monochromatic Blue Light | Total |
|---|---|---|---|
| United States | 52 | 52 | 104 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Patient Data will be kept on file and disclosed at discretion of the PI in accordance with Baylor College of Medicine regulations
This study is completed, as verified in Feb 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Baylor College of Medicine