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

NCT03504553 | Completed

• 1 other identifier: IRB18-00203
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgery; Noise Exposure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Compliance during induction

  First 5 minutes of surgical procedure

• Presence of post anesthesia emergence delirium

  Average of 30 mins - 1 hr

• Post-discharge behavior disturbances

  Post-op day 1

• Post-discharge behavior disturbances

  Post-op day 2

• Post-discharge behavior disturbances

  Post-op day 7

Study Arms (2)

Noise reduction

EXPERIMENTAL

Reduced operating room personnel, low ambient light and soft background music during induction and emergence from anesthesia.

Other: Noise reduction

Control

NO INTERVENTION

Normal operating room environment.

Interventions

Noise reduction OTHER

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.

Noise reduction

Eligibility Criteria

• Age: 2 Years - 7 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joshua Uffman: lead

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Related Publications (1)

• Bozych M, Tram NK, Rice-Weimer J, Cartabuke RS, Tobias JD, Huffman J, Mpody C, Uffman JC. Operating Room Noise Environment and Behavior in Children Undergoing General Anesthesia: A Randomized Controlled Trial. Anesthesiol Res Pract. 2024 Aug 16;2024:4838649. doi: 10.1155/2024/4838649. eCollection 2024.

  PMID: 39185368 DERIVED

Study Officials

• Richard Cartabuke, MD

  Nationwide Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice Chair, Department of Anesthesiology & Pain Medicine

Study Record Dates

• First Submitted: April 12, 2018
• First Posted: April 20, 2018
• Study Start: October 18, 2018
• Primary Completion: August 12, 2021
• Study Completion: August 12, 2021
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

US (1)