A Phase 4 interventional study of Dexmedetomidine and Propofol in Sleep Apnea, Obstructive, sponsored by Children's Hospital Medical Center, Cincinnati. Completed at 1 site in United States. Open to participants aged 12 Months to 25 Years. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Children's Hospital Medical Center, Cincinnati · Phase 4, Interventional, and Treatment
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and propofol, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults with a history of obstructive sleep apnea (OSA) having an MRI scan.
The results of this study will help in making the best decisions regarding the anesthesia medications that are most appropriate for children, adolescents, and young adults with OSA during MRI studies.
Patients with OSA are at risk for airway obstruction (a condition that makes it difficult to breath) during sedation and anesthesia. Dexmedetomidine and propofol are safe and effective drugs regularly used by anesthesiologists. These drugs are used to put patients to sleep for operations and certain studies like MRI scans. However, there have been no studies describing the effects these drugs have on the upper airway of children, adolescents, and young adults with OSA.
1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.
This study's enrollment of 60 is above the median of 50 across 965 interventional studies indexed under Apnea.
Browse Apnea studies →Children's Hospital Medical Center, Cincinnati is the lead sponsor of 661 studies on the registry; 134 are open to participants now.
Of its 54 completed or terminated interventional studies of FDA-regulated products, 30 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Propofol
Drug: 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.
Also known as: Precedex
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.
Also known as: Diprivan
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.
Time frame: during MRI within first 10 minutes of scanning
Obstructive Index Until Recovery Room Discharge
The Obstructive Index is a count of the obstructive apnea events per hour of sleep
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes
Respiratory Disturbance Index
The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes
Needed Artificial Airway
This is the count of the number of patients who needed an artificial airway.
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes
Room Air SpO2
The patient's oxygen saturation on room air.
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes
| Milestone | Propofol | Dexmedetomidine |
|---|---|---|
| Started | 30 | 30 |
| Completed | 30 | 28 |
| Not completed | 0 | 2 |
| Withdrew: Patients failed to reach sedation level | 0 | 2 |
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.
| mm^2 | Propofol | Dexmedetomidine |
|---|---|---|
| Low Dose Sedative, Nasopharyngeal measurement | 239.9 (185.4 to 267.2) | 178.5 (148.5 to 222.4) |
| High Dose Sedative, Nasopharyngeal measurement | 201.6 (148.9 to 291.7) | 235.4 (145.0 to 258.8) |
| Low Dose Sedative, Retroglossal measurement | 115.1 (67.8 to 167.0) | 120.9 (63.6 to 179.5) |
| High dose sedative, Retroglossal measurement | 108.1 (53.6 to 134.4) | 120.5 (50.1 to 178.4) |
The Obstructive Index is a count of the obstructive apnea events per hour of sleep
| Apnea events/hour of sleep | Mild OSA and Dexmedetomidine | Mild OSA and Propofol | Moderate OSA and Dexmedetomidine | Moderate OSA and Propofol | Severe OSA and Dexmedetomidine | Severe OSA and Propofol |
|---|---|---|---|---|---|---|
| Obstructive Index Until Recovery Room Discharge | 4.2 (3.4 to 4.9) | 3.0 (2.3 to 3.5) | 8.0 (7.4 to 8.6) | 8.0 (5.9 to 8.9) | 16.7 (14.1 to 23.3) | 17.1 (14.6 to 37.0) |
The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep.
| respir.disturbance events/hr of sleep | Mild OSA and Dexmedetomidine | Mild OSA and Propofol | Moderate OSA and Dexmedetomidine | Moderate OSA and Propofol | Severe OSA and Dexmedetomidine | Severe OSA and Propofol |
|---|---|---|---|---|---|---|
| Respiratory Disturbance Index | 5.1 (4.8 to 5.4) | 3.2 (2.4 to 4.1) | 8.8 (7.7 to 9.8) | 7.1 (5.9 to 9.1) | 16.6 (14.3 to 19.6) | 25.2 (14.7 to 41.9) |
This is the count of the number of patients who needed an artificial airway.
| Number of artifical airway events | Mild OSA and Dexmedetomidine | Mild OSA and Propofol | Moderate OSA and Dexmedetomidine | Moderate OSA and Propofol | Severe OSA and Dexmedetomidine | Severe OSA and Propofol |
|---|---|---|---|---|---|---|
| Needed Artificial Airway | 0 | 1 | 1 | 1 | 2 | 5 |
The patient's oxygen saturation on room air.
| percentage of SpO2 | Mild OSA and Dexmedetomidine | Mild OSA and Propofol | Moderate OSA and Dexmedetomidine | Moderate OSA and Propofol | Severe OSA and Dexmedetomidine | Severe OSA and Propofol |
|---|---|---|---|---|---|---|
| Room Air SpO2 | 87.2 (86.7 to 87.7) | 88.0 (83.0 to 91.0) | 86.3 (84.8 to 87.5) | 89.0 (87.0 to 93.0) | 84.0 (77.0 to 88.8) | 88.0 (80.4 to 88.2) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Propofol | — | 0/30 (0%) | 0/30 (0%) |
| Dexmedetomidine | — | 0/30 (0%) | 0/30 (0%) |
| Age, Categorical(Participants) | Propofol | Dexmedetomidine | Total |
|---|---|---|---|
| <=18 years | 30 | 30 | 60 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Propofol | Dexmedetomidine | Total |
|---|---|---|---|
| Mean | 8.8 (5.8 to 14.3) | 8.3 (4.7 to 16.1) | 8.6 (5.3 to 15.2) |
| Sex: Female, Male(Participants) | Propofol | Dexmedetomidine | Total |
|---|---|---|---|
| Female | 8 | 8 | 16 |
| Male | 22 | 22 | 44 |
| Region of Enrollment(participants) | Propofol | Dexmedetomidine | Total |
|---|---|---|---|
| United States | 30 | 30 | 60 |
This study is completed, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Children's Hospital Medical Center, Cincinnati