Sedation
Conditions
Keywords
Sedation, MRI
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
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.
Interventions
DRUGKetamine
Sedation medication
DRUGMidazolam
Sedation medication
DRUGDexmedetomidine
Sedation medication
Sponsors
University of Louisville
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
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 5. Planned additional procedure during the sedation encounter (non-brain MRI, lumbar puncture, EEG etc)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in Blood Pressure From Baseline | during sedation and recovery (generally 2-3 hours) | Change in blood pressure from baseline. |
| Percent Change in Heart Rate From Baseline | during sedation and recovery (generally 2-3 hours) | Change in heart rate from baseline. |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexmedetomidine and Ketamine Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
Ketamine
Dexmedetomidine | 7 |
| Dexmedetomidine and Midazolam Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
Midazolam
Dexmedetomidine | 13 |
| Total | 20 |
Baseline characteristics
| Characteristic | Dexmedetomidine and Ketamine | Dexmedetomidine and Midazolam | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 7 Participants | 13 Participants | 20 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 27 months STANDARD_DEVIATION 23 | 35 months STANDARD_DEVIATION 18 | 32.2 months STANDARD_DEVIATION 19.8 |
| BMI | 16.4 kilogram per meter squared STANDARD_DEVIATION 1.5 | 17.4 kilogram per meter squared STANDARD_DEVIATION 2.6 | 17.0 kilogram per meter squared STANDARD_DEVIATION 2.2 |
| MRI Indication Ataxia | 0 Participants | 4 Participants | 4 Participants |
| MRI Indication Diplopia | 0 Participants | 1 Participants | 1 Participants |
| MRI Indication Seizure | 7 Participants | 7 Participants | 14 Participants |
| MRI Indication Syncope | 0 Participants | 1 Participants | 1 Participants |
| Primary Diagnosis Ataxia | 0 participants | 4 participants | 4 participants |
| Primary Diagnosis Diplopia | 0 participants | 1 participants | 1 participants |
| Primary Diagnosis seizure | 7 participants | 7 participants | 14 participants |
| Primary Diagnosis syncope | 0 participants | 1 participants | 1 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 7 participants | 13 participants | 20 participants |
| Sex: Female, Male Female | 4 Participants | 7 Participants | 11 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 13 |
| other Total, other adverse events | 0 / 7 | 0 / 13 |
| serious Total, serious adverse events | 0 / 7 | 0 / 13 |
Outcome results
Primary
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
Time frame: a total of 2-3 hours during sedation and recovery.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Dexmedetomidine and Ketamine | The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours) | Hypotension | 0 Participants |
| Dexmedetomidine and Ketamine | The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours) | Bradycardia | 0 Participants |
| Dexmedetomidine and Midazolam | The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours) | Hypotension | 0 Participants |
| Dexmedetomidine and Midazolam | The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours) | Bradycardia | 0 Participants |
Secondary
Percent Change in Blood Pressure From Baseline
Change in blood pressure from baseline.
Time frame: during sedation and recovery (generally 2-3 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine and Ketamine | Percent Change in Blood Pressure From Baseline | -18.7 percent change from baseline | Standard Deviation 12.2 |
| Dexmedetomidine and Midazolam | Percent Change in Blood Pressure From Baseline | -14.9 percent change from baseline | Standard Deviation 11.8 |
p-value: 0.52t-test, 1 sided
Secondary
Percent Change in Heart Rate From Baseline
Change in heart rate from baseline.
Time frame: during sedation and recovery (generally 2-3 hours)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Dexmedetomidine and Ketamine | Percent Change in Heart Rate From Baseline | -29.9 percent change from baseline | Standard Deviation 7.5 |
| Dexmedetomidine and Midazolam | Percent Change in Heart Rate From Baseline | -29.6 percent change from baseline | Standard Deviation 11.1 |
p-value: 0.96t-test, 1 sided
Secondary
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.
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)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Dexmedetomidine and Ketamine | The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery | 0 Participants |
| Dexmedetomidine and Midazolam | The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery | 0 Participants |