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

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504553
• Other study ID #: IRB18-00203
• Status: Completed
• Phase: N/A
• Start date: October 18, 2018
• Est. completion date: August 12, 2021

Study information

• Verified date: January 2024
• Source: Nationwide Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: August 12, 2021
• Est. primary completion date: August 12, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 7 Years

Eligibility

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.

Related Conditions & MeSH terms

• Noise Exposure
• Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Nationwide Children's Hospital	Columbus	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Joshua Uffman

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Noise exposure	Assess the peak and cumulative level of noise exposure to the patient during the entire surgery.	Average of 30 mins - 3 hrs