Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

NCT ID: NCT03285243

Last Updated: 2024-02-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 104 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-11-03
• Study Completion Date: 2020-06-02

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.

Conditions

Emergence Delirium; Anesthesia Emergence Delirium

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Blue light - non monochromatic

Group Type: SHAM_COMPARATOR

Monochromatic blue light

Intervention Type: DEVICE

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

Monochromatic blue light

Group Type: EXPERIMENTAL

Monochromatic blue light

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

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;

• Minimum Eligible Age: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Baylor College of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Adam Adler MD, MS, FAAP

Assistant Professor of Anesthesiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam Adler, MD

Role: PRINCIPAL_INVESTIGATOR

Baylor College of Medicine

Locations

Texas childrens Hospital

Houston, Texas, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34496743 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

H-39878

Identifier Type: -

Identifier Source: org_study_id