Dexmedetomidine and Ketamine in MRI

• ClinicalTrials.gov Identifier: NCT02652507
• Recruitment Status: Completed
• First Posted: January 12, 2016
• Last Update Posted: July 24, 2019
• Sponsor: Children's Hospital Medical Center, Cincinnati
• Information provided by (Responsible Party): Children's Hospital Medical Center, Cincinnati

Tracking Information

• First Submitted Date: January 8, 2016
• First Posted Date: January 12, 2016
• Last Update Posted Date: July 24, 2019
• Study Start Date: June 2016
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current

Current Secondary Outcome Measures (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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dexmedetomidine and Ketamine in MRI
• Official Title: 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: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Magnetic Resonance Imaging

Intervention

• 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

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

Recruitment Information

• Recruitment Status: Completed
• Estimated Enrollment (submitted: January 8, 2016): 22
• Original Estimated Enrollment: Same as current
• Actual Study Completion Date: May 2018
• Actual Primary Completion Date: May 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 1 Year to 18 Years (Child, Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02652507
• Other Study ID Numbers: 2016-0106
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Children's Hospital Medical Center, Cincinnati
• Study Sponsor: Children's Hospital Medical Center, Cincinnati
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mohamed Mahmoud, MD; Children's Hospital Medical Center, Cincinnati

• PRS Account: Children's Hospital Medical Center, Cincinnati
• Verification Date: July 2019