Propofol in Emergence Agitation
Condition: Emergence Agitation
MeSH terms: Psychomotor Agitation; Emergence Delirium
Intervention: Propofol
Intervention description: IV, single bolus at completion of anesthetic, 0.1 ml/kg
Intervention MeSH terms: Propofol
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 99.0
Sex: All
Minimum age: 12 Months
Maximum age: 6 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        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.