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OpenTrials
Completed

NCT Number: NCT03504553

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

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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Key information

Conditions

Surgery Noise Exposure

Age range

2 year–7 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Noise reduction

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.

Primary outcomes

  1. Anxiety during induction

    Time frame: First 5 minutes of surgical procedure

    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.

Secondary outcomes

  1. Compliance during induction

    Time frame: First 5 minutes of surgical procedure

    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.

  2. Presence of post anesthesia emergence delirium

    Time frame: Average of 30 mins - 1 hr

    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.

  3. Post-discharge behavior disturbances

    Time frame: Post-op day 1

    Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.

  4. Post-discharge behavior disturbances

    Time frame: Post-op day 2

    Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.

  5. Post-discharge behavior disturbances

    Time frame: Post-op day 7

    Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.

  6. Noise exposure

    Time frame: Average of 30 mins - 3 hrs

    Assess the peak and cumulative level of noise exposure to the patient during the entire surgery.

Sponsors and collaborators

Lead sponsor

Joshua Uffman

Other

Registry information

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Apr 20, 2018
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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