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finding it difficult to recruit.
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Sedation is required in infants and children to successfully complete MRI while maintaining respiratory and hemodynamic stability. Limited access to the patient may pose a safety risk during MRI examination. Therefore, appropriate drugs need to be selected, administered, and titrated to achieve these objectives. Propofol is commonly used for sedation in children in the MRI setting because of its predictability, rapid onset, and offset of action. Dexmedetomidine has sedative and analgesic properties without affecting cardiovascular and respiratory stability. The rationale of this research is to assess the effect of these drugs on the upper airway and validate their use in children with upper airway disorders.
Objectives The objective of this study is to compare the changes in upper airway configuration at the level of soft palate, base of tongue and tip of the epiglottis in children sedated with dexmedetomidine and propofol in children undergoing MRI.
We hypothesize that the upper airway caliber will be smaller in children receiving propofol than with dexmedetomidine.
Primary Outcome To measure the cross-sectional area (CSA) of the upper airway at the level of soft palate, base of the tongue and epiglottis in both groups of children at high doses of propofol and dexmedetomidine and thus compare the decrease in CSA with increasing doses of both drugs.
Secondary Outcomes To measure the
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| dexmedetomidine | Active Comparator |
| |
| propofol | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexmedetomidine | Drug | Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway. After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate. |
| Measure | Description | Time Frame |
|---|---|---|
| Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged. | When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be done |
| Measure | Description | Time Frame |
|---|---|---|
| Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged | When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of devoflurane, measurement will be obtained |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Uma R Parekh, MBBS, FRCA | Milton S. Hershey Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Penn State Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
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1 participant was excluded prior to assignment group
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| ID | Title | Description |
|---|---|---|
| FG000 | Dexmedetomidine | Dexmedetomidine: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway. After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate. |
| FG001 | Propofol | propofol: Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion. After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min. Image acquisitions will be repeated approximately 5 min after the increase in infusion rate. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Dexmedetomidine | Dexmedetomidine: Administer dexmedetomidine at 1mcg/kg over 10min followed by an infusion of dexmedetomidine at 1mcg/kg/hr and image the upper airway. After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of dexmedetomidine 2mcg/kg followed by increase in the infusion rate to 3mcg/kg/hr. Upper airway images will be repeated 5mins after increasing infusion Image acquisitions will be repeated approximately 5 min after the increase in infusion rate. |
| 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 | Cross-sectional Area (CSA) of the Upper Airway at the Level of Soft Palate, Base of the Tongue and Tip of the Epiglottis | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged. | Posted | Mean | Standard Deviation | mm2 | When expired sevoflurane is 0% during the procedure on an average of 5 - 10 mins after discontinuation of sevoflurane, airway measurements will be done |
|
through study procedure up to subject discharge, an average of 2 hour
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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: after inhalational induction with 6% in sevoflurane in O2:N2O (30:70),administer dexmedetomidine at 2 mcg/kg over 10min followed by an infusion of dexmedetomidine at 3mcg/kg/hr and image the upper airway when expired sevoflurane in 0 |
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Early termination leading to small numbers of subjects recruited.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Uma R Parekh, MBBS, DNB, FRCA, FFARCSI | Penn State Health Milton S. Hershey Medical Center | 717531-4264 | uparekh@pennstatehealth.psu.edu |
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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 | Sep 26, 2018 | Apr 26, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D056151 | Airway Remodeling |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D020927 | Dexmedetomidine |
| D015742 | Propofol |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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|
|
| propofol | Drug | Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion. After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min. Image acquisitions will be repeated approximately 5 min after the increase in infusion rate. |
|
|
| Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged | When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of sevoflurane, measurement will be obtained |
| BG001 | Propofol | propofol: Administer propofol bolus at 2mg/kg,followed by an infusion of propofol at 100 mcg/kg/min. Upper airway images will be obtained 5 mins after the patient is stable on this infusion. After the initial set of images is obtained, the depth of anesthesia will be increased by administering a bolus dose of 1mg/kg propofol and infusion increased to 240mcg/kg/min. Image acquisitions will be repeated approximately 5 min after the increase in infusion rate. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0
|
|
| Secondary | Anteroposterior Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged | Posted | Mean | Standard Deviation | mm | When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of devoflurane, measurement will be obtained |
|
|
|
| Secondary | Transverse Diameter of the Airway at the Level of Soft Palate, Base of Tongue and Tip of the Epiglottis | At each anatomic level, measurements will be obtained during three successive respiratory cycles and values will be averaged | Posted | Mean | Standard Deviation | mm | When the the expired sevoflurane is 0% during the procedure on an average of 5 - 10 min after discontinuation of sevoflurane, measurement will be obtained |
|
|
|
| 0 |
| 10 |
| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Propofol | Propofol: After inhalation induction with 6% in sevoflurane in O2:N2O (30:70),administer propofol bolus at 3mg/kg,followed by an infusion of propofol at 240mcg/kg/min. Upper airway images will be obtained when expired sevoflurane is 0 | 0 | 14 | 0 | 14 | 0 | 14 |
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| D010636 |
| Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| AP of the Tip of the Epiglottis |
|
| Tr of the Tip of the Epiglottis |
|