Dexmedetomidine and Propofol for Pediatric MRI Sedation | NCT03513757

Dexmedetomidine and Propofol for Pediatric MRI Sedation | NCT03513757 | Trialant

Description Module

Detailed Description

The purpose of this study is to compare the results of combining two anesthetic medications (dexmedetomidine and propofol) in low doses with a standard dose of a single drug that is commonly used to provide sedation/anesthesia for MRI studies in young children (propofol).

Recent studies and the FDA have raised concerns that anesthesia for longer than three hours may have effects on behavior and learning. Although investigators do not know if these effects are caused by drugs or the medical condition a child is being treated for, in December 2016, the FDA published the information below regarding anesthesia for children:

General anesthetic and sedation drugs are used to put people into a deep sleep so they do not feel pain during surgery or procedures.

These drugs are usually injected into a vein or breathed in through a mask. General anesthetic and sedation drugs are widely used to ensure the health, safety, and comfort of children and adults undergoing surgery or other procedures.

Recent studies in children suggest that a single, relatively short exposure to general anesthetic and sedation drugs in infants or toddlers is unlikely to have negative effects on behavior or learning. More research is still needed to fully understand how anesthetics might affect brain development, especially longer or repeated exposures and in more vulnerable children. Anesthetic and sedation drugs are necessary for infants, children, and pregnant women who require surgery or other painful and stressful procedures. https://www.fda.gov/Drugs/DrugSafety/ucm532356.htm Research in neonatal and infant animals has demonstrated that sedative and anesthetic agents, like propofol, produce adverse effects on brain development, including loss of brain cells resulting in long-term, possibly permanent changes in learning and behavior. These adverse effects appear to occur mostly after prolonged periods of sedation or anesthesia (generally greater than 3 hours) and when brain development is occurring at a rapid rate (which roughly occurs in children under 3 years of age). It is not known if similar adverse effects occur in humans. Study participants should be advised that the drugs used to accomplish the procedure may have the potential to increase the loss of nerve cells in the developing brain of young child and that the clinical significance of any such changes is not known. There are some animal studies that suggests dexmedetomidine may be better for a growing infant's brain. However, the effects of dexmedetomidine alone or in combination with propofol on the developing brain have not been thoroughly tested to date." The drugs used for the MRI scan in this study will be chosen randomly. Half the patients will receive small doses of propofol and dexmedetomidine. The other half will receive propofol administered constantly throughout the scan. Other drugs that may be used include sevoflurane and nitrous oxide at the start of the sedation (for placing an intravenous), lidocaine (to reduce the pain of propofol injection) and glycopyrrolate (to prevent the heart rate from decreasing too low. Investigators will record 5 additional blood pressures and heart rates. If additional medications are required to complete the scan, investigators will administer whatever is necessary. At the end of the study, an observer will record the time it takes for spontaneous eye opening, to be able to drink liquids and/or eat and to behave as before the study. Also, it is very important that investigators learn in the following day or two how the participant behaved at home; whether eating, behavior and sleeping were unusual. For that reason, the investigator will call the participant a day or so following the MRI scan.

The investigators expect to recruit 70 children between the ages of 12 and 72 months for the study and hope to have the study completed in 2018.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
propofol	Active Comparator	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions.	Drug: propofol Drug: Lidocaine 1% Injectable Solution Drug: Nitrous Oxide Drug: Sevoflurane
propofol dexmedetomidine	Experimental	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions.	Drug: propofol Drug: Dexmedetomidine Drug: Glycopyrrolate Drug: Lidocaine 1% Injectable Solution Drug: Nitrous Oxide Drug: Sevoflurane

Interventions

Name	Type	Description	Arm Group Labels	Other Names
propofol	Drug	propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists	propofol propofol dexmedetomidine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficiency of Propofol Dexmedetomidine Sedation Compared With Propofol Infusion	Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.	through study completion, an average of 2 hours

Measure	Description	Time Frame
Total Propofol Administered	total propofol administered (mg/kg)	up to 90 minutes
Dexmedetomidine Dose	dexmedetomidine dose (mcg/kg)

Contacts/Locations Module

Name	Affiliation	Role
Susan P Taylor, MD, MPH	Children's Hospital and Health System Foundation, Wisconsin	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Children's Hospital of Wisconsin		Milwaukee	Wisconsin	53226	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
28177852	Background	Andropoulos DB, Greene MF. Anesthesia and Developing Brains - Implications of the FDA Warning. N Engl J Med. 2017 Mar 9;376(10):905-907. doi: 10.1056/NEJMp1700196. Epub 2017 Feb 8. No abstract available.
18055659	Background	Vespasiano M, Finkelstein M, Kurachek S. Propofol sedation: intensivists' experience with 7304 cases in a children's hospital. Pediatrics. 2007 Dec;120(6):e1411-7. doi: 10.1542/peds.2007-0145.

Arm/Group Information

ID	Title	Description
FG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists
FG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists Dexmedetomidine: single dose dexmedetomidine administered at start of sedation. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mic/kg

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00022 subjects FG00118 subjects
COMPLETED		FG00022 subjects FG00118 subjects
NOT COMPLETED		FG0000 subjects FG0010 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mic/kg/min. Dose will be increased by 50 mic/kg/min up to 300 mic/kg/min for movement and decreased to 150 mic/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Units	Counts
Participants	BG000

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Continuous			Median

Outcome Measures Module

Outcome Measures

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

Efficiency of Propofol Dexmedetomidine Sedation Compared With Propofol Infusion

Time (minutes) from anesthesia start to readiness for discharge from the department to home or clinic.

Posted

Median

Inter-Quartile Range

minutes

through study completion, an average of 2 hours

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mic/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mic/kg/minute propofol infusion if movement persists

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
respiratory events during induction/anesthesia/recovery	Injury, poisoning and procedural complications		Systematic Assessment	desaturation, cough, breath hold

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Susan Taylor MD	Medical College of Wisconsin	414-266-3560		sutaylor@mcw.edu

Uploaded Document Information

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	Oct 19, 2019	Feb 19, 2020	Prot_SAP_001.pdf

Condition Browse Module

ID	Term
D006261	Headache
D009369	Neoplasms
D004827	Epilepsy
D017253	Neurofibromatoses
D006849	Hydrocephalus
D000008	Abdominal Neoplasms

ID	Term
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

Intervention Browse Module

ID	Term
D015742	Propofol
D020927	Dexmedetomidine
D006024	Glycopyrrolate
D008012	Lidocaine
D009609	Nitrous Oxide
D000077149	Sevoflurane

ID	Term
D010636	Phenols
D001555	Benzene Derivatives
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Race and Ethnicity Not Collected

Race and Ethnicity were not collected from any participant.

Count of Participants

Participants

Title

Denominators

Categories

- ParticipantsBG0000
- ParticipantsBG0010
- ParticipantsBG0020

Title	Measurements
	BG0020

Secondary

Total Propofol Administered

total propofol administered (mg/kg)

Posted

Median

Inter-Quartile Range

mg/kg

up to 90 minutes

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG00010.6(9.2 to 12.9) OG0013.0(2 to 3.7)

Secondary

Dexmedetomidine Dose

dexmedetomidine dose (mcg/kg)

Posted

Median

Inter-Quartile Range

mcg/kg

up to 90 minutes

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0000(0 to 0) OG0010.70(0.70 to 1)

Secondary

Glycopyrrolate Dose

glycopyrrolate dose (mcg/kg)

Posted

Median

Inter-Quartile Range

mcg/kg

5 minutes

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0000(0 to 0) OG0014.2(4 to 4.8)

Secondary

Lidocaine Dose

lidocaine dose (mg/kg)

Posted

Median

Inter-Quartile Range

mg/kg

up to 90 minutes

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0001.00(0.97 to 1.03) OG0011.00(0.96 to 1.05)

Secondary

Nitrous Oxide

documentation of use

Posted

Number

participants

up to 10 minutes

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG00018 OG00117

Secondary

Sevoflurane

sevoflurane induction time of 5 minutes

Posted

Number

participants

sevoflurane induction time up to 10 minutes

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG00018 OG00117

Secondary

Eye Opening

minutes from completion of scan to spontaneous eye opening

Posted

Median

Inter-Quartile Range

minutes

up to 90 minutes

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG00028(23 to 34) OG0013(2 to 4)

Secondary

Oral/Enteral Intake

minutes from completion of scan to oral/enteral intake

Posted

Median

Inter-Quartile Range

minutes

up to 2 hours

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG00033(29 to 42) OG00114(7 to 17)

Secondary

Discharge Ready

minutes from completion of scan to discharge ready

Posted

Median

Inter-Quartile Range

minutes

up to 2 hours

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG00040(33 to 53) OG00117(9 to 31)

Secondary

Sleep Pattern

parental observation of deviation from child's normal habit obtained through follow-up phone call

Posted

Number

participants

up to 48 hours

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mic/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0012

Secondary

Irritability

behavior deemed inappropriate and a deviation from child's normal though parental observation obtained through follow-up phone call

Posted

Number

participants

up to 48 hours

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mcg/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0003 OG0010

Secondary

Delirium

Pediatric Anesthesia Emergence Delirium (PAED) score greater than 12 as defined by Sikich and Lerman. 0 = no delirium, 20 = worst possible delirium; 5 categories scored from 0-4 additive for a maximum score of 20. Categories 1-3 are scored the same and categories ar scored inversely as described. 1. Child makes contact with caregiver, 2. child's actions are purposeful, 3. child is aware of his surroundings. For each of these category, score 0 for extremely, 1 for very much, 2 for quite a bit, 3 for just a little, 4 for not at all. The other 2 categories 4. Child is restless and 5 Child is inconsolable are scored as 0 for not at all, 1 for just a little, 2 for quite a bit, 3 for very much, 4 for extremely

Posted

Number

participants

up to 24 hours.

ID	Title	Description
OG000	Propofol	Each patient will receive 1 mg/kg lidocaine followed by 2 mg/kg propofol IV once prior to continuous propofol infusion for MRI sedation at 200 mcg/kg/min. Dose will be increased by 50 mcg/kg/min up to 300 mcg/kg/min for movement and decreased to 150 mcg/kg/min if no movement after 30 minutes. Additional 1 mg/kg propofol bolus administered at time of each movement. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 200 mcg/kg/minute propofol infusion if movement persists.
OG001	Propofol Dexmedetomidine	Each patient will receive: 1 mg/kg lidocaine, 2 mg/kg propofol, 4 mcg/kg glycopyrrolate and single dose dexmedetomidine administered prior to scan. Dexmedetomidine dose is dependent on expected duration of scan and will be equal to 1 mcg/kg/hour x duration of scan in hours. 1 mg/kg propofol will be administered for movement up to 2 times. For continued movement after that, begin propofol infusion at 150 mcg/kg/min. Study to be terminated if movement persists despite above interventions. propofol: propofol 2 mg/kg at start of procedure; 2 mg/kg for movement, 150-300 mcg/kg/minute propofol infusion if movement persists. Dexmedetomidine: single dose dexmedetomidine administered at start of sedation in the propofol-dexmedetomidine group. Dosing is based upon anticipated duration of scan from 30 - 75 minutes and will range from 0.5 mcg/kg to 1.25 mcg/kg. Glycopyrrolate: 4 mcg/kg glycopyrrolate will be administered at the start of sedation in the propofol-dexmedetomidine group.

Units	Counts
Participants	OG00022 OG00118

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0010