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

• Sponsor: University of Louisville (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02129426
• Collaborator: (none)
• Enrollment: 21
• Location: 1
• Arms: 2
• Actual Duration (Months): 43
• Patients Per Site Per Month: 0.5

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Sedation	Drug: Ketamine; Drug: Midazolam; Drug: Dexmedetomidine	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 21 participants
• Allocation: Randomized
• 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: Aug 1, 2014
• Actual Primary Completion Date: Mar 1, 2018
• Actual Study Completion Date: Mar 1, 2018

Arms and Interventions

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: Midazolam; Sedation medication; Drug: Dexmedetomidine; Sedation medication

Outcome Measures

Primary Outcome Measures

1. The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours) [a total of 2-3 hours during sedation and recovery.]

   number of participants developing hypotension and or bradycardia

Secondary Outcome Measures

1. Percent Change in Heart Rate From Baseline [during sedation and recovery (generally 2-3 hours)]

   Change in heart rate from baseline.

2. Percent Change in Blood Pressure From Baseline [during sedation and recovery (generally 2-3 hours)]

   Change in blood pressure from baseline.

3. The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery [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 number of participants with adverse recovery-related behaviors, based on the PAED scores, between the 2 treatment arms.

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 18 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Planned additional procedure during the sedation encounter (non-brain MRI, lumbar puncture, EEG etc)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville

Investigators

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

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 2, 2014

More Information

Publications

None provided.

• Responsible Party: John W Berkenbosch, Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT02129426
• Other Study ID Numbers: Ket-Dex/M-Dex MRI
• First Posted: May 2, 2014
• Last Update Posted: Jul 14, 2021
• Last Verified: Jul 1, 2021

• Keywords provided by John W Berkenbosch, Professor, University of Louisville: Sedation; MRI
• Additional relevant MeSH terms: Midazolam; Dexmedetomidine; Ketamine

Study Results

Participant Flow

Arm/Group Title	Dexmedetomidine and Ketamine	Dexmedetomidine and Midazolam
Arm/Group Description	Subjects will already be getting Dexmedetomidine and Ketamine for their routine care. Ketamine Dexmedetomidine	Subjects will already be getting Dexmedetomidine and Midazolam for their routine care. Midazolam Dexmedetomidine
Period Title: Overall Study
STARTED	7	13
COMPLETED	0	0
NOT COMPLETED	7	13

Baseline Characteristics

Arm/Group Title	Dexmedetomidine and Ketamine	Dexmedetomidine and Midazolam	Total
Arm/Group Description	Subjects will already be getting Dexmedetomidine and Ketamine for their routine care. Ketamine Dexmedetomidine	Subjects will already be getting Dexmedetomidine and Midazolam for their routine care. Midazolam Dexmedetomidine	Total of all reporting groups
Overall Participants	7	13	20
Age (Count of Participants)
<=18 years	7 100%	13 100%	20 100%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	0 0%	0 0%	0 0%
Age (months) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [months]	27 (23)	35 (18)	32.2 (19.8)
Sex: Female, Male (Count of Participants)
Female	4 57.1%	7 53.8%	11 55%
Male	3 42.9%	6 46.2%	9 45%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%	0 0%	0 0%
Asian	0 0%	0 0%	0 0%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	0 0%	0 0%	0 0%
White	0 0%	0 0%	0 0%
More than one race	0 0%	0 0%	0 0%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	7 100%	13 100%	20 100%
BMI (kilogram per meter squared) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kilogram per meter squared]	16.4 (1.5)	17.4 (2.6)	17.0 (2.2)
Primary Diagnosis (participants) [Number]
seizure	7 100%	7 53.8%	14 70%
Diplopia	0 0%	1 7.7%	1 5%
Ataxia	0 0%	4 30.8%	4 20%
syncope	0 0%	1 7.7%	1 5%
MRI Indication (Count of Participants)
Seizure	7 100%	7 53.8%	14 70%
Diplopia	0 0%	1 7.7%	1 5%
Ataxia	0 0%	4 30.8%	4 20%
Syncope	0 0%	1 7.7%	1 5%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine and Ketamine	Dexmedetomidine and Midazolam
Arm/Group Description	Subjects will already be getting Dexmedetomidine and Ketamine for their routine care. Ketamine Dexmedetomidine	Subjects will already be getting Dexmedetomidine and Midazolam for their routine care. Midazolam Dexmedetomidine
Measure Participants	7	13
Hypotension	0 0%	0 0%
Bradycardia	0 0%	0 0%

2. Secondary Outcome

Title	Percent Change in Heart Rate From Baseline
Description	Change in heart rate from baseline.
Time Frame	during sedation and recovery (generally 2-3 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine and Ketamine	Dexmedetomidine and Midazolam
Arm/Group Description	Subjects will already be getting Dexmedetomidine and Ketamine for their routine care. Ketamine Dexmedetomidine	Subjects will already be getting Dexmedetomidine and Midazolam for their routine care. Midazolam Dexmedetomidine
Measure Participants	7	13
Mean (Standard Deviation) [percent change from baseline]	-29.9 (7.5)	-29.6 (11.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexmedetomidine and Ketamine, Dexmedetomidine and Midazolam
	Comments
	Type of Statistical Test	Other
	Comments	t-test comparison of the two groups
Statistical Test of Hypothesis	p-Value	0.96
	Comments
	Method	t-test, 1 sided
	Comments

3. Secondary Outcome

Title	Percent Change in Blood Pressure From Baseline
Description	Change in blood pressure from baseline.
Time Frame	during sedation and recovery (generally 2-3 hours)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine and Ketamine	Dexmedetomidine and Midazolam
Arm/Group Description	Subjects will already be getting Dexmedetomidine and Ketamine for their routine care. Ketamine Dexmedetomidine	Subjects will already be getting Dexmedetomidine and Midazolam for their routine care. Midazolam Dexmedetomidine
Measure Participants	7	13
Mean (Standard Deviation) [percent change from baseline]	-18.7 (12.2)	-14.9 (11.8)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Dexmedetomidine and Ketamine, Dexmedetomidine and Midazolam
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.52
	Comments
	Method	t-test, 1 sided
	Comments

4. Secondary Outcome

Title	The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery
Description	This study will compare the number of participants with adverse recovery-related behaviors, based on the PAED scores, between the 2 treatment arms.
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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Dexmedetomidine and Ketamine	Dexmedetomidine and Midazolam
Arm/Group Description	Subjects will already be getting Dexmedetomidine and Ketamine for their routine care. Ketamine Dexmedetomidine	Subjects will already be getting Dexmedetomidine and Midazolam for their routine care. Midazolam Dexmedetomidine
Measure Participants	7	13
Count of Participants [Participants]	0 0%	0 0%

Adverse Events

Time Frame	24 hours
Arm/Group Title	Dexmedetomidine and Ketamine		Dexmedetomidine and Midazolam
Arm/Group Description	Subjects will already be getting Dexmedetomidine and Ketamine for their routine care. Ketamine Dexmedetomidine		Subjects will already be getting Dexmedetomidine and Midazolam for their routine care. Midazolam Dexmedetomidine
All Cause Mortality
	Dexmedetomidine and Ketamine		Dexmedetomidine and Midazolam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/13 (0%)
Serious Adverse Events
	Dexmedetomidine and Ketamine		Dexmedetomidine and Midazolam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/13 (0%)
Other (Not Including Serious) Adverse Events
	Dexmedetomidine and Ketamine		Dexmedetomidine and Midazolam
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/7 (0%)		0/13 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.