Dexmedetomidine and Ketamine in MRI

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2018-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Magnetic Resonance Imaging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Dexmedetomidine

Intervention Type DRUG

2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h

Ketamine

Intervention Type DRUG

Bolus dose 2 mg/kg after first set of research images are obtained

Interventions

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Dexmedetomidine

2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h

Intervention Type DRUG

Ketamine

Bolus dose 2 mg/kg after first set of research images are obtained

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

1 Year

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No