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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-04-30

Study Completion Date

2016-01-31

Brief Summary

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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

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Conditions

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Emergence Delirium Parasomnias

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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children's sleep habits questionnaire

survey of children's sleep habits completed by parent

Intervention Type OTHER

Eligibility Criteria

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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)

Minimum Eligible Age

1 Year

Maximum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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2015-0116

Identifier Type: -

Identifier Source: org_study_id