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Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03285243
Enrollment
104
Registered
2017-09-15
Start date
2017-11-03
Completion date
2020-06-02
Last updated
2024-02-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia Emergence Delirium, Emergence Delirium

Keywords

Delirium, anesthesia, pediatrics

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.

Interventions

DEVICEMonochromatic 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

Baylor College of Medicine
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)

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.

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.

Eligibility

Sex/Gender
ALL
Age
2 Years to 6 Years
Healthy volunteers
Yes

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;

Design outcomes

Primary

MeasureTime frameDescription
Number of Participants With Emergence Delirium Following Anesthesia in Children30 minutesAssessment if monochromatic light reduces the absolute incidence of emergence delirium following general anesthesia (as a binary: emergence delirium vs. no emergence delirium)

Secondary

MeasureTime frameDescription
Number of Participants With PAED Scale Score of 12 or More for 30 Minutes After Baseline30 minutesAssessment 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

Countries

United States

Participant flow

Recruitment details

Recruitment was performed between November 3, 2017 and June 2, 2020

Participants by arm

ArmCount
Blue Light - Non Monochromatic
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
52
Monochromatic Blue Light
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
52
Total104

Baseline characteristics

CharacteristicMonochromatic Blue LightTotalBlue Light - Non Monochromatic
Age, Categorical
<=18 years
52 Participants104 Participants52 Participants
Age, Categorical
>=65 years
0 Participants0 Participants0 Participants
Age, Categorical
Between 18 and 65 years
0 Participants0 Participants0 Participants
Age, Continuous4.7 years
STANDARD_DEVIATION 1.3
4.5 years
STANDARD_DEVIATION 1.4
4.2 years
STANDARD_DEVIATION 1.4
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Asian
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Black or African American
0 Participants0 Participants0 Participants
Race (NIH/OMB)
More than one race
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
52 Participants104 Participants52 Participants
Race (NIH/OMB)
White
0 Participants0 Participants0 Participants
Region of Enrollment
United States
52 participants104 participants52 participants
Sex: Female, Male
Female
24 Participants48 Participants24 Participants
Sex: Female, Male
Male
28 Participants56 Participants28 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 520 / 52
other
Total, other adverse events
0 / 520 / 52
serious
Total, serious adverse events
0 / 520 / 52

Outcome results

Primary

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

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Blue Light - Non MonochromaticNumber of Participants With Emergence Delirium Following Anesthesia in Children17 Participants
Monochromatic Blue LightNumber of Participants With Emergence Delirium Following Anesthesia in Children3 Participants
p-value: 0.001Chi-squared
Secondary

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

Population: Patient had Emergence Delirium or a PAED Scale Score of 12 or more for 30 minutes after Baseline(n, %)

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Blue Light - Non MonochromaticNumber of Participants With PAED Scale Score of 12 or More for 30 Minutes After Baseline27 Participants
Monochromatic Blue LightNumber of Participants With PAED Scale Score of 12 or More for 30 Minutes After Baseline12 Participants
p-value: 0.002Regression, Logistic

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026