Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine
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|ClinicalTrials.gov Identifier: NCT02129426|
Recruitment Status : Terminated (Unable to recruit the adequate number of subjects)
First Posted : May 2, 2014
Last Update Posted : April 4, 2018
|Condition or disease||Intervention/treatment||Phase|
|Sedation||Drug: Ketamine Drug: Midazolam Drug: Dexmedetomidine||Not Applicable|
The will be a randomized, double-blind, prospective study. All patients referred to UCSS for brain MRI and for whom dexmedetomidine would otherwise be the sedation regimen of choice will be eligible for enrollment. The investigators propose to limit the study to patients undergoing only brain MRI as these studies are of a predictable length (25-30 minutes); therefore the sedation regimen can be more easily standardized. Parents of eligible patients would be approached prior to or during the pre-sedation assessment and told about the study and, if they agree to enroll, informed consent would be obtained. Assent will be obtained from children 7 years of age and greater, if they are otherwise developmentally capable of giving assent. The goal is to enroll 50 subjects (25 per treatment group) which would be sufficient to detect a 25% or greater difference in the mean maximal heart rate or blood pressure decrease from baseline between the 2 groups.
Following consent, subjects would be randomized to be sedated with either midazolam-dexmedetomidine or ketamine-dexmedetomidine and, upon achieving an appropriate depth of sedation, undergo their MRI. Monitoring during the MRI and subsequent recovery would occur in compliance with the current Norton Children's Hospital Sedation policy. Recovery-related behavior would be assessed using the Pediatric Anesthesia Emergence Delirium Scale.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Health Services Research|
|Official Title:||COMPARISON OF OUTCOMES DURING MRI SEDATION WITH MIDAZOLAM-DEXMEDETOMIDINE VERSUS KETAMINE-DEXMEDETOMIDINE|
|Actual Study Start Date :||August 2014|
|Actual Primary Completion Date :||March 2018|
|Actual Study Completion Date :||March 2018|
Experimental: Dexmedetomidine and Ketamine
Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
|Drug: Ketamine Drug: Dexmedetomidine|
Active Comparator: Dexmedetomidine and Midazolam
Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
|Drug: Midazolam Drug: Dexmedetomidine|
- The incidence of hypotension and/or bradycardia during sedation [ Time Frame: parameters (blood pressure, heart rate) will be measured every 5 minutes from start of the sedation until recovery has been completed (usually less than 2 hrs). ]The study will compare the incidences of hypotension (Systolic Blood Pressure (SBP) <5% for age/gender) and/or bradycardia (Heart Rate (HR) <70 in infants, HR <60 in children 12-23 mos of age, HR <50 for subjects 24 mos of age and older) that occur within each treatment arm as well as measure the percent maximal decrease in HR and SBP from baseline in each subject and compare mean decreases in these measures between treatment groups).
- The incidence of adverse recovery-related behaviors during sedation recovery [ Time Frame: Recovery-related behaviors will be specifically measured using the "Pediatric Anesthesia Emergence Delirium (PAED)" scale every 5 minutes from procedure completion until sedation recovery is complete (usually less than 2 hrs) ]This study will compare the incidence of adverse recovery-related behaviors, based on the PAED scores, between the 2 treatment arms.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02129426
|United States, Kentucky|
|University of Louisville|
|Louisville, Kentucky, United States, 40202|
|Principal Investigator:||John W. Berkenbosch, M.D.||University of Louisville|