Propofol in Emergence Agitation

Emergence Agitation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00535613
• Other study ID #: H-2007-0069
• Status: Completed
• Phase: Phase 4
• Start date: August 2007
• Est. completion date: December 2010

Study information

• Verified date: October 2019
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Months to 6 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergence Agitation
• Emergence Delirium
• Psychomotor Agitation

Intervention

Drug:
• Propofol
IV, single bolus at completion of anesthetic, 0.1 ml/kg

Locations

Country	Name	City	State
United States	Univeristy of Wisconsin - Madison	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With Emergent Agitation	Incidence of Emergent Agitation is defined as a Paediatric Anaesthesia Emergence Delirium (PAED) score above 10 at any point at the defined protocol time points (recovery, 5, 10, 15, 20, 25, or 30 minutes)	up to 30 min post surgery
Secondary	Time Spent in Recovery Room		up to 1 hour post surgery
Secondary	Number of Participants Who Received Medication in the Recovery Room		up to 1 hour post surgery