Noise Exposure, Surgery
Conditions
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.
Interventions
OTHERNoise 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.
Sponsors
Joshua Uffman
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 7 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 1 | Parents will be contacted by phone and asked a series of 11 questions (PHBQ) to assess participants behavior following surgery. |
| Noise exposure | Average of 30 mins - 3 hrs | Assess the peak and cumulative level of noise exposure to the patient during the entire surgery. |
Countries
United States
Outcome results
None listed