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

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ClinicalTrials.gov Identifier: NCT03504553
Recruitment Status : Enrolling by invitation
First Posted : April 20, 2018
Last Update Posted : November 8, 2018
Sponsor:
Information provided by (Responsible Party):
Joshua Uffman, Nationwide Children's Hospital

Brief 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.

Condition or disease Intervention/treatment Phase
Surgery Noise Exposure Other: Noise reduction Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia
Actual Study Start Date : October 18, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Noise

Arm Intervention/treatment
Experimental: Noise reduction
Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia.
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.

No Intervention: Control
Normal operating room environment.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



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Ages Eligible for Study:   2 Years to 7 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504553


Locations
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United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
Sponsors and Collaborators
Joshua Uffman
Investigators
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Principal Investigator: Joshua Uffman, MD Nationwide Children's Hospital

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Responsible Party: Joshua Uffman, Vice-Chairman, Quality Improvement, Nationwide Children's Hospital
ClinicalTrials.gov Identifier: NCT03504553     History of Changes
Other Study ID Numbers: IRB18-00203
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: November 8, 2018
Last Verified: November 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs