Dexmedetomidine and Ketamine in MRI

Magnetic Resonance Imaging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02652507
• Other study ID #: 2016-0106
• Status: Completed
• Phase: Phase 1
• Start date: June 2016
• Est. completion date: May 2018

Study information

• Verified date: July 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: May 2018
• Est. primary completion date: May 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Magnetic Resonance Imaging

Intervention

Drug:
• Dexmedetomidine
2 mc/kg/h over ten minutes followed by a continuous infusion of 2 mcg/kg/h
• Ketamine
Bolus dose 2 mg/kg after first set of research images are obtained

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	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
Secondary	Patient movement during MRI		Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Secondary	Episodes of low oxygen saturation		Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Secondary	Placement of adjunct airway		Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Secondary	Arterial blood pressure relative to baseline before dexmedetomidine is given		Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes
Secondary	Heart rate relative to baseline before dexmedetomidine is given		Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes