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

Emergence Delirium Clinical Trial

Official title:

Determining the Incidence of Parasomnias (PS) and Emergence Delirium (ED)in the American Family Children's Hospital Patient Population

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02980549
• Other study ID #: 2015-0116
• Status: Completed
• Phase: N/A
• First received: May 5, 2015
• Last updated: November 29, 2016
• Start date: April 2015
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year to 6 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium
• Emergence Delirium
• Parasomnias
• Sleep Wake Disorders

Intervention

Other:
• children's sleep habits questionnaire
survey of children's sleep habits completed by parent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of parasomnias (PS) and emergence delirium (ED) in children		6 months	No
Secondary	score on Childrens Sleep Habits Questionnaire correlated with ED		6 months	No