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Dexmedetomidine and Ketamine in MRI

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ClinicalTrials.gov Identifier: NCT02652507
Recruitment Status : Completed
First Posted : January 12, 2016
Last Update Posted : July 24, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.


Condition or disease Intervention/treatment Phase
Magnetic Resonance Imaging Drug: Dexmedetomidine Drug: Ketamine Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Effect of a Combination of Dexmedetomidine and Ketamine Anesthesia on Upper Airway Morphology in Children
Study Start Date : June 2016
Actual Primary Completion Date : May 2018
Actual Study Completion Date : May 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Measurement of soft palate under anesthesia [ Time Frame: 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

  2. Measurement of base of tongue under anesthesia [ Time Frame: 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 Outcome Measures :
  1. Anteroposterior dimension and transverse dimension of soft palate [ Time Frame: 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

  2. Anteroposterior dimension and transverse dimension of base of tongue [ Time Frame: 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

  3. Patient movement during MRI [ Time Frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes ]
  4. Episodes of low oxygen saturation [ Time Frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes ]
  5. Placement of adjunct airway [ Time Frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes ]
  6. Arterial blood pressure relative to baseline before dexmedetomidine is given [ Time Frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes ]
  7. Heart rate relative to baseline before dexmedetomidine is given [ Time Frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes ]


Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02652507


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Mohamed Mahmoud, MD Children's Hospital Medical Center, Cincinnati
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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT02652507    
Other Study ID Numbers: 2016-0106
First Posted: January 12, 2016    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Sedation
MRI
Dexmedetomidine
Ketamine
General anesthesia
MRI of Brain
MRI of Brain/Spine
Additional relevant MeSH terms:
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Dexmedetomidine
Ketamine
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adrenergic alpha-2 Receptor Agonists
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents