Sleep Apnea, Obstructive
Conditions
Keywords
Obstructive Sleep Apnea, MRI, Pediatrics, Dexmedetomidine, Propofol, Anesthesia
Brief summary
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.
Detailed description
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.
Interventions
DRUGDexmedetomidine
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.
DRUGPropofol
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.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Months to 25 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with documented history of OSA by polysomnography who require anesthesia for MRI sleep study or MRI brain imaging study. 2. Subjects must be 12 months to 25 years of age (inclusive) 3. Either the subject (if subject's age is 18-25) or the subject's legally authorized representative has given written informed consent to participate in the study
Exclusion criteria
1. The subject has life-threatening medical conditions (American Society of Anesthesiologists Physical Status 4, 5 or 6). The American Society of Anesthesiologists (ASA) classification scale is a measure of physical status or how healthy the patient is. For our study, we will focus on children which are defined as ASA I, II or III which means a healthy child (ASA I), a child with a systemic disease that is mild and well controlled (ASA II) or a child with systemic disease that is severe and controlled (ASA III). 2. The subject is allergic to or has a contraindication to propofol or dexmedetomidine. 3. The subject has a tracheostomy or other mechanical airway device 4. The subject is not scheduled to receive anesthesia-sedation care for the MRI 5. The subject has a history or a family (parent or sibling) history of malignant hyperthermia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cross Sectional Area of the Pharyngeal Airway | during MRI within first 10 minutes of scanning | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Obstructive Index Until Recovery Room Discharge | During MRI and until recovery room discharge - approximately 30-250 minutes | The Obstructive Index is a count of the obstructive apnea events per hour of sleep |
| Respiratory Disturbance Index | During MRI and until recovery room discharge - approximately 30-250 minutes | The respiratory disturbance index is a count of respiratory disturbance events per hour of sleep. |
| Needed Artificial Airway | During MRI and until recovery room discharge - approximately 30-250 minutes | This is the count of the number of patients who needed an artificial airway. |
| Room Air SpO2 | During MRI and until recovery room discharge - approximately 30-250 minutes | The patient's oxygen saturation on room air. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 30 |
| 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. | 30 |
| Total | 60 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Patients failed to reach sedation level | 0 | 2 |
Baseline characteristics
| Characteristic | Dexmedetomidine | Propofol | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 8.3 years | 8.8 years | 8.6 years |
| Region of Enrollment United States | 30 participants | 30 participants | 60 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 16 Participants |
| Sex: Female, Male Male | 22 Participants | 22 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 30 | 0 / 30 |
| serious Total, serious adverse events | 0 / 30 | 0 / 30 |
Outcome results
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.
Time frame: during MRI within first 10 minutes of scanning
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Propofol | Cross Sectional Area of the Pharyngeal Airway | Low Dose Sedative, Nasopharyngeal measurement | 239.9 mm^2 |
| Propofol | Cross Sectional Area of the Pharyngeal Airway | High Dose Sedative, Nasopharyngeal measurement | 201.6 mm^2 |
| Propofol | Cross Sectional Area of the Pharyngeal Airway | Low Dose Sedative, Retroglossal measurement | 115.1 mm^2 |
| Propofol | Cross Sectional Area of the Pharyngeal Airway | High dose sedative, Retroglossal measurement | 108.1 mm^2 |
| Dexmedetomidine | Cross Sectional Area of the Pharyngeal Airway | High dose sedative, Retroglossal measurement | 120.5 mm^2 |
| Dexmedetomidine | Cross Sectional Area of the Pharyngeal Airway | Low Dose Sedative, Nasopharyngeal measurement | 178.5 mm^2 |
| Dexmedetomidine | Cross Sectional Area of the Pharyngeal Airway | Low Dose Sedative, Retroglossal measurement | 120.9 mm^2 |
| Dexmedetomidine | Cross Sectional Area of the Pharyngeal Airway | High Dose Sedative, Nasopharyngeal measurement | 235.4 mm^2 |
Secondary
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
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Propofol | Needed Artificial Airway | 0 Number of artifical airway events |
| Dexmedetomidine | Needed Artificial Airway | 1 Number of artifical airway events |
| Moderate OSA and Dexmedetomidine | Needed Artificial Airway | 1 Number of artifical airway events |
| Moderate OSA and Propofol | Needed Artificial Airway | 1 Number of artifical airway events |
| Severe OSA and Dexmedetomidine | Needed Artificial Airway | 2 Number of artifical airway events |
| Severe OSA and Propofol | Needed Artificial Airway | 5 Number of artifical airway events |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propofol | Obstructive Index Until Recovery Room Discharge | 4.2 Apnea events/hour of sleep |
| Dexmedetomidine | Obstructive Index Until Recovery Room Discharge | 3.0 Apnea events/hour of sleep |
| Moderate OSA and Dexmedetomidine | Obstructive Index Until Recovery Room Discharge | 8.0 Apnea events/hour of sleep |
| Moderate OSA and Propofol | Obstructive Index Until Recovery Room Discharge | 8.0 Apnea events/hour of sleep |
| Severe OSA and Dexmedetomidine | Obstructive Index Until Recovery Room Discharge | 16.7 Apnea events/hour of sleep |
| Severe OSA and Propofol | Obstructive Index Until Recovery Room Discharge | 17.1 Apnea events/hour of sleep |
Secondary
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
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propofol | Respiratory Disturbance Index | 5.1 respir.disturbance events/hr of sleep |
| Dexmedetomidine | Respiratory Disturbance Index | 3.2 respir.disturbance events/hr of sleep |
| Moderate OSA and Dexmedetomidine | Respiratory Disturbance Index | 8.8 respir.disturbance events/hr of sleep |
| Moderate OSA and Propofol | Respiratory Disturbance Index | 7.1 respir.disturbance events/hr of sleep |
| Severe OSA and Dexmedetomidine | Respiratory Disturbance Index | 16.6 respir.disturbance events/hr of sleep |
| Severe OSA and Propofol | Respiratory Disturbance Index | 25.2 respir.disturbance events/hr of sleep |
Secondary
Room Air SpO2
The patient's oxygen saturation on room air.
Time frame: During MRI and until recovery room discharge - approximately 30-250 minutes
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Propofol | Room Air SpO2 | 87.2 percentage of SpO2 |
| Dexmedetomidine | Room Air SpO2 | 88.0 percentage of SpO2 |
| Moderate OSA and Dexmedetomidine | Room Air SpO2 | 86.3 percentage of SpO2 |
| Moderate OSA and Propofol | Room Air SpO2 | 89.0 percentage of SpO2 |
| Severe OSA and Dexmedetomidine | Room Air SpO2 | 84.0 percentage of SpO2 |
| Severe OSA and Propofol | Room Air SpO2 | 88.0 percentage of SpO2 |