Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine

This study will compare 2 different sedation drugs (Ketamine and Midazolam) when they are used with another sedating medicine called Dexmedetomidine for MRI sedation. This study hopes to measure the impact each drug has on what happens during and after MRI sedation with Dexmedetomidine

Study Overview

• Status: Terminated
• Conditions: Sedation
• Intervention / Treatment: Drug: Ketamine; Drug: Dexmedetomidine; Drug: Midazolam

Detailed Description

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
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Inpatient at Kosair Children's Hospital.
2. Order placed by treating team for MRI of the brain with sedation.
3. Age less than or equal to 18 years.
4. Plan to sedate with dexmedetomidine, regardless of study participation.

Exclusion Criteria:

1. Previous adverse reaction to dexmedetomidine or clonidine
2. Current use of clonidine as a routine medication
3. Concurrent use of a heart-rate decreasing medication (digoxin, propranolol)

4. Contraindication to ketamine use

   • Intracranial hypertension or traumatic brain injury
   • Intraocular hypertension of eye trauma
   • Pulmonary hypertension requiring medical management
5. Planned additional procedure during the sedation encounter (non-brain MRI, lumbar puncture, EEG etc)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine and Ketamine; Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.	Drug: Ketamine; Sedation medication; Drug: Dexmedetomidine; Sedation medication
Active Comparator: Dexmedetomidine and Midazolam; Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.	Drug: Dexmedetomidine; Sedation medication; Drug: Midazolam; Sedation medication

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours)	number of participants developing hypotension and or bradycardia	a total of 2-3 hours during sedation and recovery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Change in Heart Rate From Baseline	Change in heart rate from baseline.	during sedation and recovery (generally 2-3 hours)
Percent Change in Blood Pressure From Baseline	Change in blood pressure from baseline.	during sedation and recovery (generally 2-3 hours)
The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery	This study will compare the number of participants with adverse recovery-related behaviors, based on the PAED scores, between the 2 treatment arms.	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)

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: John W. Berkenbosch, M.D., University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2014
• Primary Completion (Actual): March 1, 2018
• Study Completion (Actual): March 1, 2018

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: April 30, 2014
• First Posted (Estimate): May 2, 2014

Study Record Updates

• Last Update Posted (Actual): July 14, 2021
• Last Update Submitted That Met QC Criteria: July 12, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: MRI; Sedation
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Dissociative; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Excitatory Amino Acid Antagonists; Excitatory Amino Acid Agents; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Ketamine; Midazolam; Dexmedetomidine
• Other Study ID Numbers: Ket-Dex/M-Dex MRI