Clinical Trial: Propofol in Emergence Agitation
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Does a Single Dose of Propofol Decrease the Incidence of Emergence Agitation in Children?
Brief 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.
Detailed Summary:
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.
Sponsor: University of Wisconsin, Madison
Current Primary Outcome: amount of emergent agitation [ Time Frame: 3 years ]
Original Primary Outcome: amount of emergent agitation [ Time Frame: 1 year ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: University of Wisconsin, Madison
Dates:
Date Received: September 23, 2007
Date Started: August 2007
Date Completion:
Last Updated: October 9, 2015
Last Verified: October 2015
