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.

Study Overview

• Status: Completed
• Conditions: Surgery; Noise Exposure
• Intervention / Treatment: Other: Noise reduction

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 7 years (Child)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety during induction	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.	First 5 minutes of surgical procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance during induction	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.	First 5 minutes of surgical procedure
Presence of post anesthesia emergence delirium	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.	Average of 30 mins - 1 hr
Post-discharge behavior disturbances	Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.	Post-op day 1
Post-discharge behavior disturbances	Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.	Post-op day 2
Post-discharge behavior disturbances	Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.	Post-op day 7
Noise exposure	Assess the peak and cumulative level of noise exposure to the patient during the entire surgery.	Average of 30 mins - 3 hrs

Collaborators and Investigators

• Sponsor: Joshua Uffman
• Investigators: Principal Investigator: Richard Cartabuke, MD, Nationwide Children's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2018
• Primary Completion (Actual): August 12, 2021
• Study Completion (Actual): August 12, 2021

Study Registration Dates

• First Submitted: April 12, 2018
• First Submitted That Met QC Criteria: April 19, 2018
• First Posted (Actual): April 20, 2018

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: IRB18-00203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No