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

Not Applicable

Completed

• Conditions: Surgery; Noise Exposure

• Registration Number: NCT03504553
• Lead Sponsor: Joshua Uffman

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 available

Study Timeline

• Study First Submitted: 2018-04-12
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Study Start: 2018-10-18
• Primary Completion: 2021-08-12
• Study Completion: 2021-08-12
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 64

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Anxiety during induction	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

Name	Time	Method
Noise exposure	Average of 30 mins - 3 hrs	Assess the peak and cumulative level of noise exposure to the patient during the entire surgery.
Compliance during induction	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	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	Post-op day 7	Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery.

Trial Locations

Locations (1)

Nationwide Children's Hospital; 🇺🇸 Columbus, Ohio, United States