Dexmedetomidine and Propofol in Children With History of... | NCT01344759

Dexmedetomidine and Propofol in Children With History of... | NCT01344759 | Trialant

Arms/Interventions Module

Label	Type	Description	Intervention Names
Propofol	Active Comparator		Drug: Propofol
Dexmedetomidine	Active Comparator		Drug: Dexmedetomidine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexmedetomidine	Drug	Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cross Sectional Area of the Pharyngeal Airway	The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.	during MRI within first 10 minutes of scanning

Secondary Outcomes

Measure	Description	Time Frame
Obstructive Index Until Recovery Room Discharge	The Obstructive Index is a count of the obstructive apnea events per hour of sleep	During MRI and until recovery room discharge - approximately 30-250 minutes
Respiratory Disturbance Index

Contacts/Locations Module

Name	Affiliation	Role
Mohamed Mahmoud, MD	Children's Hospital Medical Center, Cincinnati	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Cincinnati Children's Hospital Medical Center		Cincinnati	Ohio	45229	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
16790626	Background	Mason KP, Zgleszewski SE, Dearden JL, Dumont RS, Pirich MA, Stark CD, D'Angelo P, Macpherson S, Fontaine PJ, Connor L, Zurakowski D. Dexmedetomidine for pediatric sedation for computed tomography imaging studies. Anesth Analg. 2006 Jul;103(1):57-62, table of contents. doi: 10.1213/01.ane.0000216293.16613.15.
10910487	Background

Arm/Group Information

ID	Title	Description
FG000	Propofol	Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
FG001	Dexmedetomidine	Dexmedetomidine: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of dexmedetomidine 1 mcg/kg will be administered over 10 minutes followed by a continuous infusion of dexmedetomidine at rate of 1 mcg/kg/h using a syringe pump.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00030 subjects FG00130 subjects
COMPLETED		FG00030 subjects FG00128 subjectsTwo of the original DEX group subjects were removed, due to receiving dexmedetomidine and propofol.
NOT COMPLETED		FG0000 subjects FG0012 subjects

Type	Comment	Reasons
Patients failed to reach sedation level		FG0000 subjects FG0012 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	Propofol	Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.
BG001	Dexmedetomidine

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

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

Cross Sectional Area of the Pharyngeal Airway

The primary outcome measures will be the cross sectional area of the pharyngeal airway of the patients measured at two levels soft palate (nasopharyngeal) and base of the tongue (retroglossal). Magnetic resonance images of the airway were obtained during low (1 mcg/kg/hr) and high (3 mcg/kg/hr) doses of DEX or low (100 mcg/kg/m) and high (200 mcg/kg/m) doses of Propofol. All were administered through an intravenous (IV) catheter.

Posted

Median

95% Confidence Interval

mm^2

during MRI within first 10 minutes of scanning

ID	Title	Description
OG000	Propofol	Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump (Low dose). Baseline airway images are obtained during this time. If a subject moves during baseline images a bolus of Propofol 0.5 mcg/kg will be given over 10 seconds and infusion rate will be increased to 120 mcg/kg/hr. If the subject moves a second time the research study will be terminated and patient will be under care of clinical team. After the initial set of airway images are obtained, a bolus dose of propofol 2 mcg/kg will be given over 2 minutes followed by an increase in the infusion rate to 200 mcg/kg/hr (high dose).

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	Propofol: Once an IV is in place, atropine 10 mcg/kg will be given. Loading dose of propofol 2 mg/kg will be administered over 2 minutes followed by a continuous infusion of propofol at rate of 100 mcg/kg/minute using a syringe pump.

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Dr. Mohamed Mahmoud	Cincinnati Children's Hosptial Medical Center	513-636-4408		Mohamed.Mahmoud@cchmc.org

Condition Browse Module

ID	Term
D020181	Sleep Apnea, Obstructive

ID	Term
D012891	Sleep Apnea Syndromes
D001049	Apnea
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases

Intervention Browse Module

ID	Term
D020927	Dexmedetomidine
D015742	Propofol

ID	Term
D007093	Imidazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Title

Denominators

Categories

Low Dose Sedative, Nasopharyngeal measurement

Title	Measurements
	OG000239.9(185.4 to 267.2) OG001178.5(148.5 to 222.4)

High Dose Sedative, Nasopharyngeal measurement

Title	Measurements
	OG000201.6(148.9 to 291.7) OG001235.4(145.0 to 258.8)

Low Dose Sedative, Retroglossal measurement

Title	Measurements
	OG000115.1(67.8 to 167.0) OG001120.9(63.6 to 179.5)

High dose sedative, Retroglossal measurement

Title	Measurements
	OG000108.1(53.6 to 134.4) OG001120.5(50.1 to 178.4)

Secondary

Obstructive Index Until Recovery Room Discharge

The Obstructive Index is a count of the obstructive apnea events per hour of sleep

Posted

Mean

Inter-Quartile Range

Apnea events/hour of sleep

During MRI and until recovery room discharge - approximately 30-250 minutes

ID	Title	Description
OG000	Mild OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG001	Mild OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
OG002	Moderate OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG003	Moderate OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
OG004	Severe OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG005	Severe OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.

Units	Counts
Participants	OG0002 OG0017 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG0004.2(3.4 to 4.9) OG0013.0(2.3 to 3.5) OG0028.0(7.4 to 8.6) OG003

Secondary

Respiratory Disturbance Index

The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.

Posted

Mean

Inter-Quartile Range

respir.disturbance events/hr of sleep

During MRI and until recovery room discharge - approximately 30-250 minutes

ID	Title	Description
OG000	Mild OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG001	Mild OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
OG002	Moderate OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG003	Moderate OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
OG004	Severe OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG005	Severe OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.

Units	Counts
Participants	OG0002 OG0017 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG0005.1(4.8 to 5.4) OG0013.2(2.4 to 4.1) OG0028.8(7.7 to 9.8) OG003

Secondary

Needed Artificial Airway

This is the count of the number of patients who needed an artificial airway.

Posted

Number

Number of artifical airway events

During MRI and until recovery room discharge - approximately 30-250 minutes

ID	Title	Description
OG000	Mild OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG001	Mild OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
OG002	Moderate OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG003	Moderate OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
OG004	Severe OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG005	Severe OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.

Units	Counts
Participants	OG0002 OG0017 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000 OG0011 OG0021 OG003

Secondary

Room Air SpO2

The patient's oxygen saturation on room air.

Posted

Mean

Inter-Quartile Range

percentage of SpO2

During MRI and until recovery room discharge - approximately 30-250 minutes

ID	Title	Description
OG000	Mild OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG001	Mild OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
OG002	Moderate OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG003	Moderate OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.
OG004	Severe OSA and Dexmedetomidine	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive DEX.
OG005	Severe OSA and Propofol	Patients were stratified by OSA severity as documented on the patient's sleep study report: mild, moderate, or severe. (Mild=obstructive index 1-5, Moderate= obstructive index >5-10, Severe=obstructive index>10) Additionally this patient was assigned to receive Propofol.

Units	Counts
Participants	OG0002 OG0017 OG00213 OG003

Title

Denominators

Categories

Title	Measurements
	OG00087.2(86.7 to 87.7) OG00188.0(83.0 to 91.0) OG00286.3(84.8 to 87.5) OG003