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

Study Overview
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Brief Summary
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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.

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

Conditions
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Surgery, Noise Exposure

Intervention / Treatment
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* Other: Noise reduction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Undergoing general anesthesia for tonsillectomy/adenoidectomy, tympanomastoidectomy, or general abdominal laparoscopic surgical procedures lasting at least 30 minutes. Receiving midazolam prior to the procedure as part of standard of care. Exclusion Criteria: Patients that are taking antidepressant medications, anxiolytic medication, analgesia medications other than acetaminophen or NSAIDs. Allergy to midazolam. History of emergence delirium. Cardiac disease, other than functional heart murmurs. Developmental delays. Parent refusal of midazolam for standard clinical care.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Noise reduction<br>Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia. | Other: Noise reduction<br>* 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.<br>|
| No Intervention: Control<br>Normal operating room environment. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety during induction | A blinded observer will assess behavior prior to and during induction/placement of face mask or insertion of an intravenous line using the mYPAS scale. | First 5 minutes of surgical procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance during induction | A blinded observer will assess behavior prior to and during induction/placement of face mask or insertion of an intravenous line using the ICC scale. | First 5 minutes of surgical procedure | 
| Presence of post anesthesia emergence delirium | Following transfer to the post anesthesia care unit (PACU) from the OR, the PAED scale will be measured every 10 minutes from arrival until discharge from PACU. | Average of 30 mins - 1 hr | 
| Post-discharge behavior disturbances | Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery. | Post-op day 1 | 
| Post-discharge behavior disturbances | Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery. | Post-op day 2 | 
| Post-discharge behavior disturbances | Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery. | Post-op day 7 | 
| Noise exposure | Assess the peak and cumulative level of noise exposure to the patient during the entire surgery. | Average of 30 mins - 3 hrs |