Univeristy of Wisconsin - Madison
Madison, Wisconsin, 53726, United States
NCT Number: NCT00535613
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.
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Notify Me12 month–6 year
All sexes
Interventional
Phase 4
Madison, Wisconsin, 53726, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(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
IV, single bolus at completion of anesthetic, 0.1 ml/kg
Time frame: up to 30 min post surgery
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)
Time frame: up to 1 hour post surgery
Time frame: up to 1 hour post surgery
University of Wisconsin, Madison
Other
Does a Single Dose of Propofol Decrease the Incidence of Emergence Agitation in Children?
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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