Skip to main content
OpenTrials
Completed

NCT Number: NCT02652507

Dexmedetomidine and Ketamine in MRI

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Magnetic Resonance Imaging

Age range

1 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexmedetomidine

Drug

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

ketamine

Drug

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Children's Hospital Medical Center, Cincinnati

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Jan 12, 2016
Registry last updated
Jul 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.