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The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia

NCT03504553 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2024-01-08

No results posted yet for this study

Summary

This project will investigate whether reduction in ambient light and elimination of noise on induction of anesthesia alters anxiety (modified Yale Preoperative Anxiety Scale or mYPAS) or compliance (induction compliance checklist or ICC scoring), alters recovery following emergence using pain scores, analgesic requirements, and emergence delirium (post anesthesia emergence delirium or PAED), or post-discharge behavior at 1, 7 and 14 days (modified post hospitalization behaviour questionnaire or PHBQ) in patients who receive anxiolytic premedication. In addition, the investigators will assess the cumulative level of nose exposure that patients experience during the perioperative period.

Conditions

  • Surgery
  • Noise Exposure

Interventions

OTHER

Noise reduction

All activity will cease when the patient enters the operating room and nonessential personnel will be removed. Ambient lighting will be reduced and communication devices muted.

Sponsors & Collaborators

  • Joshua Uffman

    lead OTHER

Principal Investigators

  • Richard Cartabuke, MD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
2 Years
Max Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-18
Primary Completion
2021-08-12
Completion
2021-08-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03504553 on ClinicalTrials.gov