Phase 4 N=99 Randomized Quadruple-blind Treatment

Propofol in Emergence Agitation

Emergence Agitation

Bottom Line

View on ClinicalTrials.gov: NCT00535613 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2019

Primary outcome: Primary: Number of Participants With Emergent Agitation — 16; 24 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 4
Interventions: Propofol (Drug)
Age: Pediatric · 0+ yrs
Sex: All
Sponsor: University of Wisconsin, Madison
Primary completion: Dec 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Emergent Agitation	16; 24	—
SECONDARY Time Spent in Recovery Room	—	—
SECONDARY Number of Participants Who Received Medication in the Recovery Room	3; 6	—

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.

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Data sourced from ClinicalTrials.gov (NCT00535613). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.