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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | propofol |
|
| 2 | Sham Comparator | no propofol |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Propofol | Drug | IV, single bolus at completion of anesthetic, 0.1 ml/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Time Spent in Recovery Room | up to 1 hour post surgery | |
| Number of Participants Who Received Medication in the Recovery Room | up to 1 hour post surgery |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Cari Meyer, MD | Univeristy of Wisconsin - Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Wisconsin - Madison | Madison | Wisconsin | 53726 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Propofol | Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg |
| FG001 | Placebo | No propofol |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Propofol | Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg |
| BG001 | Placebo | No propofol |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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) | Posted | Count of Participants | Participants | up to 30 min post surgery |
|
Up to 30 min post surgery
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Propofol | Propofol: IV, single bolus at completion of anesthetic, 0.1 ml/kg | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Cari Meyer | University of Wisconsin | (608) 265-5980 | cmeyer@wisc.edu |
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| ID | Term |
|---|---|
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D003693 | Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015742 | Propofol |
| ID | Term |
|---|---|
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
| Secondary | Time Spent in Recovery Room | The study team planned to collect post anesthesia care unit discharge time from the subject medical records, however PACU discharge time was often not recorded in routine cases during the study period. This was not anticipated by the study team and retrospective analysis was not possible for this outcome. | Posted | up to 1 hour post surgery |
|
|
| Secondary | Number of Participants Who Received Medication in the Recovery Room | Posted | Count of Participants | Participants | up to 1 hour post surgery |
|
|
|
| 49 |
| 0 |
| 49 |
| 0 |
| 49 |
| EG001 | Placebo | No propofol | 0 | 50 | 0 | 50 | 0 | 50 |
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| D009422 |
| Nervous System Diseases |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |