Dexmedetomidine and Ketamine in MRI
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ClinicalTrials.gov Identifier: NCT02652507 |
Recruitment Status :
Completed
First Posted : January 12, 2016
Last Update Posted : July 24, 2019
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Tracking Information | ||||
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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 |
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Original Primary Outcome Measures ICMJE | Same as current | |||
Change History | ||||
Current Secondary Outcome Measures ICMJE |
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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. |
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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 |
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Condition ICMJE | Magnetic Resonance Imaging | |||
Intervention ICMJE |
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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:
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Estimated Enrollment ICMJE |
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:
Exclusion Criteria:
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Sex/Gender ICMJE |
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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 | |||
Responsible Party | Children's Hospital Medical Center, Cincinnati | |||
Study Sponsor ICMJE | Children's Hospital Medical Center, Cincinnati | |||
Collaborators ICMJE | Not Provided | |||
Investigators ICMJE |
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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 |