Clinical trial NCT02652507: Dexmedetomidine and Ketamine in MRI
Official title: Effect of a Combination of Dexmedetomidine and Ketamine Anesthesia on Upper Airway Morphology in Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Magnetic Resonance Imaging
Keywords: Sedation
MRI
Dexmedetomidine
Ketamine
General anesthesia
MRI of Brain
MRI of Brain/Spine
Lead sponsor: Children's Hospital Medical Center, Cincinnati
Sponsor class: OTHER
First posted: 2016-01-12
Enrollment: 22
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Measurement of soft palate under anesthesia
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
measure: Measurement of base of tongue under anesthesia
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Secondary outcomes:
measure: Anteroposterior dimension and transverse dimension of soft palate
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
measure: Anteroposterior dimension and transverse dimension of base of tongue
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
measure: Patient movement during MRI
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
measure: Episodes of low oxygen saturation
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
measure: Placement of adjunct airway
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
measure: Arterial blood pressure relative to baseline before dexmedetomidine is given
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
measure: Heart rate relative to baseline before dexmedetomidine is given
timeFrame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital Medical Center
state: Ohio
Study officials:
affiliation: Children's Hospital Medical Center, Cincinnati
name: Mohamed Mahmoud, MD
role: PRINCIPAL_INVESTIGATOR
References: