NCT00535613

Propofol in Emergence Agitation

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 12 Months – 6 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Emergence Agitation

Interventions

Type	Name	Description
DRUG	Propofol	IV, single bolus at completion of anesthetic, 0.1 ml/kg

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-12-01
• Completion: 2010-12-01
• First posted: 2007-09-26
• Last updated: 2019-10-21
• Results posted: 2019-10-09

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study