Dexmedetomidine and Ketamine in MRI

Phase 1

Completed

• Conditions: Magnetic Resonance Imaging
• Interventions: Drug: Dexmedetomidine; Drug: Ketamine

• Registration Number: NCT02652507
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-01-08
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-12
• Study Start: 2016-06
• Primary Completion: 2018-05
• Study Completion: 2018-05
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-23
• Last Update Posted: 2019-07-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anesthesia for MRI	Dexmedetomidine	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.
Anesthesia for MRI	Ketamine	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.

Primary Outcome Measures

Name	Time	Method
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
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

Secondary Outcome Measures

Name	Time	Method
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
Heart rate relative to baseline before dexmedetomidine is given	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
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
Patient movement during MRI	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

Trial Locations

Locations (1)

Cincinnati Children's Hospital Medical Center; 🇺🇸 Cincinnati, Ohio, United States