Propofol in Emergence Agitation



Status:Completed
Conditions:Neurology
Therapuetic Areas:Neurology
Healthy:No
Age Range:Any - 6
Updated:4/21/2016
Start Date:August 2007
End Date:December 2010

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Does a Single Dose of Propofol Decrease the Incidence of Emergence Agitation in Children?

The purpose of the study is to see if a small dose of propofol given intravenously (through
a needle into a vein) at the end of anesthesia can make it less likely that children will be
agitated as the come out of the anesthetic.

Emergence agitation is defined as a mental disturbance during the recovery from general
anesthesia. It consists of confusion, disorientation, delusions, and hallucinations. It
manifests in children as some combination of restlessness, moaning, inconsolable crying,
involuntary physical activity, and thrashing about. This puts patients at risk of injuring
themselves or their caregivers, causing bleeding or disruption of their surgical repair, and
pulling out IVs and drains. It can be difficult to maintain necessary vital sign monitoring
in these agitated patients, and constant one-on-one nursing is often required. When
emergence agitation occurs, all members of the healthcare team, and the parents report
dissatisfaction with the quality of the child's recovery from anesthesia.

Propofol is a commonly used intravenous anesthetic agent. Studies have compared continuous
infusions of intravenous propofol versus inhalational sevoflurane for the maintenance of
anesthesia. These have shown a significant decrease in the incidence of emergence agitation
in the patients who received the propofol infusions. This proposed study will investigate
the effects of a single bolus dose of propofol at the conclusion of a sevoflurane
inhalational anesthetic.

Inclusion Criteria:

- Age: 12 months to 6 years old

- Planned surgery/procedure: The goal is to enroll patients who will not have pain when
they awake from anesthesia. We will include patients who are having magnetic
resonance imaging (MRI) under anesthesia, or an eye exam under anesthesia. We will
also include those patients who are having a surgery in which a regional or caudal
block is part of the planned anesthetic. This will be small orthopedic procedures in
the lower extremities; or urologic or general surgical procedures below the level of
the umbilicus. These patients have been chosen because the regional/caudal block
should result in the patient not having pain when they awake from anesthesia.

(The caudal block is a single epidural injection of local anesthetic that is done when the
pediatric patient is under general anesthesia. It is a routine procedure that results in
numbness below the level of the umbilicus, and gives relief of pain, for about 8 hours.)

Examples of orthopedic surgeries include, but are not limited to:

Removal of an extra digit or syndactyly repair Club foot releases Lower extremity tendon
releases or lengthenings Lower extremity tendon transfers Removal of hardware

Examples of urologic surgeries include, but are not limited to:

Circumcision or circumcision revision hypospadias repair Chordee repair Orchiopexy
Orchiectomy

Examples of general pediatric surgeries include, but are not limited to:

Inguinal hernia repair Rectal muscle biopsies Excision of lower extremity or lower
abdominal mass Burn scar releases and skin grafting

Exclusion Criteria:

- Obstructive sleep apnea—Patients with sleep apnea are not ideal candidates for
removal of their endotracheal tube or laryngeal mask airway while still somewhat
anesthetized. It is preferable to extubate these patients awake.

- Developmental delays—Patients with developmental delays may not interact with their
environment, make eye contact, have purposeful actions, or be aware of their
surroundings even when at their baseline pre-operatively. It would be difficult to
evaluate these features of emergence agitation in children who demonstrate this
behavior on a routine basis.

- Psychological disorders—Patients with psychological disorders may have the same
issues as those with developmental delays when it comes to evaluating their behavior
after anesthesia.

- Egg white allergy—Propofol is contraindicated in patients with egg white allergies
due to risk of allergy to the propofol lecithin base.
We found this trial at
1
site
Madison, Wisconsin 53792
?
mi
from
Madison, WI
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