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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03504553
Recruitment Status : Enrolling by invitation
First Posted : April 20, 2018
Last Update Posted : November 20, 2019
Sponsor:
Information provided by (Responsible Party):
Joshua Uffman, Nationwide Children's Hospital

Tracking Information
First Submitted Date  ICMJE April 12, 2018
First Posted Date  ICMJE April 20, 2018
Last Update Posted Date November 20, 2019
Actual Study Start Date  ICMJE October 18, 2018
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03504553 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 19, 2018)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia
Official Title  ICMJE The Effect of a Reduced Noise Environment on Induction and Emergence Behavior in Children Undergoing General Anesthesia
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Surgery
  • Noise Exposure
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: Noise reduction
    Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia.
    Intervention: Other: Noise reduction
  • No Intervention: Control
    Normal operating room environment.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Enrolling by invitation
Estimated Enrollment  ICMJE
 (submitted: April 19, 2018)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2020
Estimated Primary Completion Date December 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 7 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03504553
Other Study ID Numbers  ICMJE IRB18-00203
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Joshua Uffman, Nationwide Children's Hospital
Study Sponsor  ICMJE Joshua Uffman
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Joshua Uffman, MD Nationwide Children's Hospital
PRS Account Nationwide Children's Hospital
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP