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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-18

Study Completion Date

2021-08-12

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.

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Detailed Description

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Conditions

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Surgery Noise Exposure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Noise reduction

Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia.

Group Type EXPERIMENTAL

Noise reduction

Intervention Type OTHER

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.

Control

Normal operating room environment.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type OTHER

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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No