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The overall goal of this project is to determine the role of anesthetic management in children undergoing cardiac surgery utilizing CPB in the setting of fast tracking and early extubation. An ideal anesthetic technique would ensure abolishing or diminishing stress response as would be evident by the stress markers levels and the level of two cerebral injury biomarkers (S 100 B and NSE). This should translate to better immediate postoperative outcome and hopefully improve both the short and the long term neurodevelopmental outcome in these children. The project is prospective, randomized and blinded study. The first and second aim of the study should be conducted over 2 year period. Our long term aim will be concluded when these children reach the school age.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dexmedetomidine | Experimental | Dexmedetomidine in addition to 15 µg/kg of fentanyl |
|
| Placebo | Placebo Comparator | Normal saline as a placebo in addition to 15 µg/kg of fentanyl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug |
|
| |
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cytokine Levels | Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively. | From baseline to 24 hrs post-op |
| Change in Hormone Levels | ACTH, cortisol, epinephrine, & norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively. | From baseline to 24 hrs post-op |
| Change in Bayley Cognitive Composite Scores | Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment. | From baseline to 1 year post-op |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Bayley Language Composite Scores | Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment. |
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Inclusion Criteria:
Patients with the following diagnosis:
Exclusion Criteria:
Patients with the diagnosis of AVSD and pulmonary hypertension
Patients less than 1 year and require any of the following repairs:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nationwide Children's Hospital | Columbus | Ohio | 43205 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Dexmedetomidine in addition to 15 µg/kg of fentanyl Dexmedetomidine |
| FG001 | Placebo | Normal saline as a placebo in addition to 15 µg/kg of fentanyl Placebo |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 5, 2022 |
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| Drug |
|
|
| From baseline to 1 year post-op |
| Change in Bayley Motor Composite Scores | Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment. | From baseline to 1 year post-op |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | Dexmedetomidine in addition to 15 µg/kg of fentanyl Dexmedetomidine |
| BG001 | Placebo | Normal saline as a placebo in addition to 15 µg/kg of fentanyl Placebo |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | months |
| |||||||||||||||
| 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 |
| ||||||||||||||||
| Diagnosis | Count of Participants | Participants |
| ||||||||||||||||
| Weight | Mean | Standard Deviation | kilograms |
|
| 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 | Change in Cytokine Levels | Cytokine levels in plasma samples will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively. | Posted | Mean | Standard Deviation | picograms per milliliter | From baseline to 24 hrs post-op |
|
|
| ||||||||||||||||||||||||||||||||||||
| Primary | Change in Hormone Levels | ACTH, cortisol, epinephrine, & norepinephrine will be measured at induction of anesthesia (baseline), after sternotomy, after initiation of CPB, at the conclusion of surgery (separation from CPB and administration of protamine and prior to skin closure) and at 24 hours post-operatively. | Posted | Mean | Standard Deviation | picograms per milliliter | From baseline to 24 hrs post-op |
|
| |||||||||||||||||||||||||||||||||||||
| Primary | Change in Bayley Cognitive Composite Scores | Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment. | Posted | Mean | Standard Deviation | score on a scale | From baseline to 1 year post-op |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bayley Language Composite Scores | Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested prior to discharge from the hospital, at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment. | Posted | Mean | Standard Deviation | score on a scale | From baseline to 1 year post-op |
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | Change in Bayley Motor Composite Scores | Children will have a baseline neurodevelopmental Bayley score during the preoperative period. These children will be retested at their post-op cardiology visit (usually 1-3 months post-op), six month and one year postoperatively to evaluate neurodevelopment progress. Mean score of 100 (SD=15) at the 50th percentile signifies mid-average functioning, scores below 85 (1 SD below the mean), at the 16th percentile, indicate mild impairment of being 'at risk' of developmental delay. Score below 70 (2 SD below the mean), at the second percentile, indicate moderate to severe impairment. | Posted | Mean | Standard Deviation | score on a scale | From baseline to 1 year post-op |
|
|
48 hours after 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 | Dexmedetomidine | Dexmedetomidine in addition to 15 µg/kg of fentanyl Dexmedetomidine | 0 | 14 | 0 | 14 | 0 | 14 |
| EG001 | Placebo | Normal saline as a placebo in addition to 15 µg/kg of fentanyl Placebo | 0 | 16 | 0 | 16 | 0 | 16 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Aymen Naguib | Nationwide Children's Hosp. | 614-722-4200 | Aymen.Naguib@nationwidechildrens.org |
| Jun 18, 2025 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D006330 | Heart Defects, Congenital |
| ID | Term |
|---|---|
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D006331 | Heart Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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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 |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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| Between 18 and 65 years |
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| >=65 years |
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| Tetralogy of Fallot |
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| Atrioventricular septal defect |
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| Post-bypass TNF-alpha |
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| End of surgery TNF-alpha |
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| 24 hr. post-op TNF-alph |
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| Baseline IL-6 |
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| Post-sternotomy IL-6 |
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| Post-bypass IL-6 |
|
| End of surgery IL-6 |
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| 24 hr. post-op IL-6 |
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| Baseline IL-8 |
|
| Post-sternotomy IL-8 |
|
| Post-bypass IL-8 |
|
| End of surgery IL-8 |
|
| 24 hr. post-op IL-8 |
|
| Baseline IL-10 |
|
| Post-sternotomy IL-10 |
|
| Post-bypass IL-10 |
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| End of surgery IL-10 |
|
| 24 hr. post-op IL-10 |
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