Effect of Monochromatic Light on Incidence of Emergence Delirium in Children

NCT03285243 | Completed Results FDA Device

• 1 other identifier: H-39878
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Emergence Delirium; Anesthesia Emergence Delirium

Keywords

Delirium, anesthesia, pediatrics

Outcome Measures

Primary Outcomes (1)

• 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)

  30 minutes

Secondary Outcomes (1)

• Number of Participants With PAED Scale Score of 12 or More for 30 Minutes After Baseline

  30 minutes

Study Arms (2)

Blue light - non monochromatic

SHAM COMPARATOR

Device: Monochromatic blue light

Monochromatic blue light

EXPERIMENTAL

Device: Monochromatic blue light

Interventions

Monochromatic blue light 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

Blue light - non monochromatic; Monochromatic blue light

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• American Society of Anesthesiologist Classification of 1,2
• Patients ages 2-6 years
• Routine tonsillectomy and adenoidectomy

You may not qualify if:

• 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;

Sponsors & Collaborators

• Baylor College of Medicine: lead

Study Sites (1)

Texas childrens Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

• 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.

  PMID: 34496743 DERIVED

MeSH Terms

Conditions

Emergence Delirium; Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Results Point of Contact

• Title: Adam Adler
• Organization: Baylor college of Medicine

Adam.adler@bcm.edu

832-8245800

Study Officials

• Adam Adler, MD

  Baylor College of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Model Details: 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.

Study Record Dates

• First Submitted: September 13, 2017
• First Posted: September 15, 2017
• Study Start: November 3, 2017
• Primary Completion: April 30, 2020
• Study Completion: June 2, 2020
• Last Updated: February 29, 2024
• Results First Posted: February 29, 2024

Record last verified: 2024-02

Locations

US (1)