Dexmedetomidine and Ketamine in MRI

Study Overview
=================
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.

Official Title
-----------------
Effect of a Combination of Dexmedetomidine and Ketamine Anesthesia on Upper Airway Morphology in Children

Conditions
-----------------
Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Ketamine


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Anesthesia for MRI<br>All patients will receive the same drugs. A loading dose of dexmedetomidine of 2 mcg/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h. Bolus dose 2 mg/kg of ketamine will be given after the initial set of research images have been taken. | Drug: Dexmedetomidine<br>* 2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h<br>Drug: Ketamine<br>* Bolus dose 2 mg/kg after first set of research images are obtained<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of soft palate under anesthesia | MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | 
| Measurement of base of tongue under anesthesia | MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anteroposterior dimension and transverse dimension of soft palate | MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | 
| Anteroposterior dimension and transverse dimension of base of tongue | MRI images for research will be taken 4 times during the MRI; estimated additional 6 minutes will be added to the MRI scan | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | 
| 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 | 
| Placement of adjunct airway |  | Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes | 
| 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sedation, MRI, Dexmedetomidine, Ketamine, General anesthesia, MRI of Brain, MRI of Brain/Spine