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

J

Joshua Uffman

Status

Completed

Conditions

Noise Exposure
Surgery

Treatments

Other: Noise reduction

Study type

Interventional

Funder types

Other

Identifiers

NCT03504553
IRB18-00203

Details and patient eligibility

About

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.

Enrollment

64 patients

Sex

All

Ages

2 to 7 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

64 participants in 2 patient groups

Noise reduction
Experimental group
Description:
Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia.
Treatment:
Other: Noise reduction
Control
No Intervention group
Description:
Normal operating room environment.

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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