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Dexmedetomidine and Ketamine in MRI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 8, 2016
First Posted Date  ICMJE January 12, 2016
Last Update Posted Date July 24, 2019
Study Start Date  ICMJE June 2016
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • 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
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 8, 2016)
  • 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
  • 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
  • Patient movement during MRI [ Time Frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes ]
  • Episodes of low oxygen saturation [ Time Frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes ]
  • Placement of adjunct airway [ Time Frame: Participants will be followed for the duration of the procedure; estimated 60 - 120 minutes ]
  • 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 ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Dexmedetomidine and Ketamine in MRI
Official Title  ICMJE Effect of a Combination of Dexmedetomidine and Ketamine Anesthesia on Upper Airway Morphology in Children
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Magnetic Resonance Imaging
Intervention  ICMJE
  • 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
Study Arms  ICMJE 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.

Interventions:
  • Drug: Dexmedetomidine
  • Drug: Ketamine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: January 8, 2016)		 22
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE May 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 1 Year to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02652507
Other Study ID Numbers  ICMJE 2016-0106
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Children's Hospital Medical Center, Cincinnati
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Children's Hospital Medical Center, Cincinnati
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mohamed Mahmoud, MD Children's Hospital Medical Center, Cincinnati
PRS Account Children's Hospital Medical Center, Cincinnati
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP