Skip to main content
OpenTrials
Completed

NCT Number: NCT02980549

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Autism
  • Severe developmental delay
  • Children receiving clonidine
  • Medication for seizures
  • Children who have received ED treatment prior to a diagnosis of ED (clonidine, dexmedetomidine, or propofol)

Treatment and study plan

children's sleep habits questionnaire

Other

survey of children's sleep habits completed by parent

Primary outcomes

  1. Prevalence of parasomnias (PS) and emergence delirium (ED) in children

    Time frame: 6 months

Secondary outcomes

  1. score on Childrens Sleep Habits Questionnaire correlated with ED

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 2, 2016
Registry last updated
Dec 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.