Magnetic Resonance Imaging
Conditions
Keywords
Sedation, MRI, Dexmedetomidine, Ketamine, General anesthesia, MRI of Brain, MRI of Brain/Spine
Brief summary
The purpose of this research study is to examine the effects of two commonly used anesthetic drugs, dexmedetomidine and ketamine, have on the shape and muscle tone of the upper airway in children, adolescents, and young adults. The results of this study will help in making the best decisions regarding the anesthesia medications used for sedation outside of the operating room.
Detailed description
Upper airway obstruction is a common problem in spontaneously breathing patients under anesthesia. This study is examining the effects of combining dexmedetomidine and ketamine on the muscle tone and airway configuration in children under anesthesia. The hypothesis is adding ketamine to dexmedetomidine will not significantly reduce airway caliber or morphology when compared to previously collected data using dexmedetomidine alone.
Interventions
DRUGDexmedetomidine
2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h
DRUGKetamine
Bolus dose 2 mg/kg after first set of research images are obtained
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
* Patient requires anesthesia for a MRI scan of the brain or MRI brain/spine * Patient must be 1 to 18 years of age * Patients legally authorized representative has given written informed consent to participate in the study
Exclusion criteria
* Allergy to dexmedetomidine or ketamine * History or obstructive sleep apnea * The patient has a life-threatening medical condition (ASA status 4, 5, or 6) * The patient is not scheduled to receive anesthesia sedation for the MRI * Patient has a history or a family history of malignant hyperthermia
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measurement of soft palate under anesthesia | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan |
| Measurement of base of tongue under anesthesia | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient movement during MRI | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | — |
| Episodes of low oxygen saturation | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | — |
| Anteroposterior dimension and transverse dimension of soft palate | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan |
| Arterial blood pressure relative to baseline before dexmedetomidine is given | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | — |
| Heart rate relative to baseline before dexmedetomidine is given | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | — |
| Placement of adjunct airway | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | — |
| Anteroposterior dimension and transverse dimension of base of tongue | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan |
Countries
United States
Outcome results
None listed