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This study is trying to see if using precedex pre-operatively prevents emergence delirium in pediatric (ages 1-7) patients undergoing strabismus surgery.
Emergence delirium (ED) is a complex behavioral disturbance characterized by psychomotor agitation, perceptual disturbances, delusions, and disorientation during recovery from general anesthesia. In the population of subjects who undergo strabismus surgery, there are multiple factors that may increase the risk of ED. These include age, typically preschool children aged 1-7 years, rapid surgical times with rapid awakening, use of sevoflurane as the primary anesthetic, and surgically-induced postoperative visual disturbance. The aims of this study are: 1) To examine whether post-induction treatment with an α-2 receptor agonist, precedex (dexmedetomidine), decreases postoperative emergence agitation after strabismus surgery compared to placebo, and 2) to determine whether treatment has any effect on postoperative pain, nausea/vomiting, number of pain-related interventions, and time to PACU discharge. We hypothesize that precedex will attenuate the ED response greater than placebo or a lower dose after strabismus surgery and will reduce PACU pain scores without increasing PACU length of stay.
Inclusion:
i. Pediatric patients aged 1-7 years of age ii. American Society of Anesthesiologists (ASA) physical status I-II iii. No significant laboratory abnormalities
Exclusion:
i. Presence of medicated behavioral disorder ii. Subjects for which precedex, opiates, benzodiazepines, or inhalational anesthetics are contraindicated iii. Parental refusal
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | dexmedetomidine/precedex |
|
| Placebo | Placebo Comparator | patients receive saline solution. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery | Length of PACU stay (around 3 hours on average) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Receiving Pain Medication | Length of PACU stay (around 3 hours on average) | |
| Post-op Pain Interventions | Length of PACU stay (around 3 hours on average) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jason Brown, MD | NYU School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NYU Langone Medical Center | New York | New York | 10016 | United States |
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Patient's familes were approached on the day of surgery and spoken to privately in the pre-op area. Fliers were placed at the phthalmalogist's offices so were generally aware of the study ahead of time.
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes |
| FG001 | Placebo | patients receive saline solution. Placebo: intraoperative dose of intravenous placebo |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes |
| BG001 | Placebo | patients receive saline solution. Placebo: intraoperative dose of intravenous placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Percentage of Patients Experiencing Pediatric Emergence Delirium in Strabismus Surgery | Posted | Number | percentage of participants | Length of PACU stay (around 3 hours on average) |
|
|
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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 | Dexmedetomidine | dexmedetomidine/precedex Dexmedetomidine: intravenous dose of dexmedetomidine 0.3 mcg/kg over 5 minutes |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Assistant Professor, Department of Anesthesiology, Perioperative Care, and Pain Medicine | NYU School of Medicine | 212.263.5072 | wanda.chin@nyumc.org |
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| ID | Term |
|---|---|
| D013285 | Strabismus |
| D000071257 | Emergence Delirium |
| ID | Term |
|---|---|
| D015835 | Ocular Motility Disorders |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Placebo | Other | intraoperative dose of intravenous placebo |
|
|
| Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications |
| Length of PACU stay (around 3 hours on average) |
| Time to Arousal | Length of PACU stay (around 3 hours on average) |
| Time to PACU Discharge | Length of PACU stay (around 3 hours on average) |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| Participants |
|
|
| Secondary | Percentage of Participants Receiving Pain Medication | Posted | Number | percentage of participants | Length of PACU stay (around 3 hours on average) |
|
|
|
| Secondary | Post-op Pain Interventions | Posted | Number | number of pain interventions/group | Length of PACU stay (around 3 hours on average) |
|
|
|
| Secondary | Percentage of Participants Requiring Post-operative Nausea and Vomiting (PONV) Rescue Medications | Posted | Number | percentage of participants | Length of PACU stay (around 3 hours on average) |
|
|
|
| Secondary | Time to Arousal | Posted | Mean | Standard Deviation | minutes | Length of PACU stay (around 3 hours on average) |
|
|
|
| Secondary | Time to PACU Discharge | Posted | Mean | Standard Deviation | minutes | Length of PACU stay (around 3 hours on average) |
|
|
|
| 0 |
| 32 |
| 0 |
| 32 |
| EG001 | Placebo | patients receive saline solution. Placebo: intraoperative dose of intravenous placebo | 0 | 31 | 0 | 31 |
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| D003693 |
| Delirium |
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D000077324 |
| Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |