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History of Changes for Study: NCT02652507
Dexmedetomidine and Ketamine in MRI
Latest version (submitted July 23, 2019) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 January 8, 2016 None (earliest Version on record)
2 January 26, 2016 Conditions and Study Status
3 June 9, 2016 Study Status and Oversight
4 July 25, 2016 Recruitment Status, Study Status and Contacts/Locations
5 April 4, 2017 Study Status and Study Design
6 November 9, 2017 Study Status
7 April 4, 2018 Recruitment Status, Study Status and Contacts/Locations
8 January 31, 2019 Recruitment Status and Study Status
9 July 23, 2019 Study Status
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Study NCT02652507
Submitted Date:  January 8, 2016 (v1)

Open or close this module Study Identification
Unique Protocol ID: 2016-0106
Brief Title: Dexmedetomidine and Ketamine in MRI
Official Title: Effect of a Combination of Dexmedetomidine and Ketamine Anesthesia on Upper Airway Morphology in Children
Secondary IDs:
Open or close this module Study Status
Record Verification: January 2016
Overall Status: Not yet recruiting
Study Start: March 2016
Primary Completion: March 2018 [Anticipated]
Study Completion: June 2018 [Anticipated]
First Submitted: January 8, 2016
First Submitted that
Met QC Criteria:
January 8, 2016
First Posted: January 12, 2016 [Estimate]
Last Update Submitted that
Met QC Criteria:
January 8, 2016
Last Update Posted: January 12, 2016 [Estimate]
Open or close this module Sponsor/Collaborators
Sponsor: Children's Hospital Medical Center, Cincinnati
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug:
U.S. FDA-regulated Device:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Magnetic Resonance Imaging
MRI Spine
MRI Brain
Keywords: Sedation
MRI
Dexmedetomidine
Ketamine
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Other
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 22 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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.

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
Open or close this module Outcome Measures
Primary Outcome Measures:
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 Outcome Measures:
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 ]

Open or close this module Eligibility
Minimum Age: 1 Year
Maximum Age: 18 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Mohamed Mahmoud, MD
Telephone: 513-636-4200
Email: mohamed.mahmoud@cchmc.org
Study Officials: Mohamed Mahmoud, MD
Principal Investigator
Children's Hospital Medical Center, Cincinnati
Locations:
Open or close this module IPDSharing
Plan to Share IPD:
Open or close this module References
Citations:
Links:
Available IPD/Information:

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