How Common Are Sleep Disorders and Problems With Emergence From Anesthesia in Surgical Patients

Completed

• Conditions: Parasomnias; Emergence Delirium

• Registration Number: NCT02980549
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

Emergence delirium (ED), also called emergence agitation or post-anesthetic excitement, is defined as a dissociated state of consciousness, occurring on awakening from general anesthesia, in which children exhibit psychomotor agitation, crying and thrashing and are not consolable for a period of time, usually 5-15 minutes. Emergence delirium is a common problem in pre-school children, with estimates of the incidence ranging from 10-70% of children in this age group. These children are agitated, seemingly unaware of their surroundings, and typically do not respond to parents or caregivers. They are therefore at risk for self-inflicted traumatic injury and complications secondary to disruptions of intravenous lines, surgical incisions, or drains. Children with ED typically require more resources in the postoperative period than children who do not exhibit ED. Predicting the likelihood of ED would allow for better allocation of resources in the post-anesthetic care unit (PACU).

The peak incidence of ED in children occurs in the same age range at which the peak incidence of parasomnias (PS) occurs. The description of parasomnias is strikingly similar to the description of ED; the American Academy of Sleep Medicine defines parasomnias as "undesirable physical events or experiences that occur during entry into sleep, within sleep or during arousals from sleep." Parasomnias can be diagnosed using a sleep questionnaire.

The purpose of this pilot study is to determine the incidence of ED and PS in our population, in order to determine the number of patients necessary to enroll in a larger study to either confirm or reject the hypothesis that ED and PS are correlated.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-04
• Study First Submitted: 2015-05-05
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Status Verified: 2016-11
• Study First Submitted QC: 2016-11-29
• Last Update Submitted: 2016-11-29
• Study First Posted: 2016-12-02
• Last Update Posted: 2016-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Pediatric patients age 1-6 (inclusive) scheduled for elective ENT or urologic surgery
2. ASA I or II
3. Presence of a caregiver who is familiar with the child's sleep history

Exclusion Criteria

1. Autism
2. Severe developmental delay
3. Children receiving clonidine
4. Medication for seizures
5. Children who have received ED treatment prior to a diagnosis of ED (clonidine, dexmedetomidine, or propofol)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of parasomnias (PS) and emergence delirium (ED) in children	6 months

Secondary Outcome Measures

Name	Time	Method
score on Childrens Sleep Habits Questionnaire correlated with ED	6 months