Dexmedetomidine and Ketamine in MRI

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

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.

Study Overview

• Status: Completed
• Conditions: Magnetic Resonance Imaging
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Ketamine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cincinnati, Ohio, United States, 45229
      • Cincinnati Children's Hospital Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 year to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Anesthesia for MRI; 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; 2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h; Drug: Ketamine; Bolus dose 2 mg/kg after first set of research images are obtained

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

Collaborators and Investigators

• Sponsor: Children's Hospital Medical Center, Cincinnati

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): May 1, 2018
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: January 8, 2016
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 12, 2016

Study Record Updates

• Last Update Posted (Actual): July 24, 2019
• Last Update Submitted That Met QC Criteria: July 23, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: MRI; Ketamine; Sedation; Dexmedetomidine; General anesthesia; MRI of Brain; MRI of Brain/Spine
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Hypnotics and Sedatives; Ketamine; Dexmedetomidine
• Other Study ID Numbers: 2016-0106