Trial Outcomes & Findings for Comparison of Outcomes During MRI Sedation With Midazolam-dexmedetomidine Versus Ketamine-dexmedetomidine (NCT NCT02129426)
NCT ID: NCT02129426
Last Updated: 2021-07-14
Results Overview
number of participants developing hypotension and or bradycardia
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
21 participants
Primary outcome timeframe
a total of 2-3 hours during sedation and recovery.
Results posted on
2021-07-14
Participant Flow
Participant milestones
| Measure |
Dexmedetomidine and Ketamine
Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
Ketamine
Dexmedetomidine
|
Dexmedetomidine and Midazolam
Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
Midazolam
Dexmedetomidine
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
13
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
7
|
13
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race data was not collected.
Baseline characteristics by cohort
| Measure |
Dexmedetomidine and Ketamine
n=7 Participants
Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
Ketamine
Dexmedetomidine
|
Dexmedetomidine and Midazolam
n=13 Participants
Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
Midazolam
Dexmedetomidine
|
Total
n=20 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=7 Participants
|
13 Participants
n=13 Participants
|
20 Participants
n=20 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=20 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=7 Participants
|
0 Participants
n=13 Participants
|
0 Participants
n=20 Participants
|
|
Age, Continuous
|
27 months
STANDARD_DEVIATION 23 • n=7 Participants
|
35 months
STANDARD_DEVIATION 18 • n=13 Participants
|
32.2 months
STANDARD_DEVIATION 19.8 • n=20 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=7 Participants
|
7 Participants
n=13 Participants
|
11 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=7 Participants
|
6 Participants
n=13 Participants
|
9 Participants
n=20 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
|
Race (NIH/OMB)
Asian
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
|
Race (NIH/OMB)
White
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
0 Participants
Race data was not collected.
|
|
Region of Enrollment
United States
|
7 participants
n=7 Participants
|
13 participants
n=13 Participants
|
20 participants
n=20 Participants
|
|
BMI
|
16.4 kilogram per meter squared
STANDARD_DEVIATION 1.5 • n=7 Participants
|
17.4 kilogram per meter squared
STANDARD_DEVIATION 2.6 • n=13 Participants
|
17.0 kilogram per meter squared
STANDARD_DEVIATION 2.2 • n=20 Participants
|
|
Primary Diagnosis
seizure
|
7 participants
n=7 Participants
|
7 participants
n=13 Participants
|
14 participants
n=20 Participants
|
|
Primary Diagnosis
Diplopia
|
0 participants
n=7 Participants
|
1 participants
n=13 Participants
|
1 participants
n=20 Participants
|
|
Primary Diagnosis
Ataxia
|
0 participants
n=7 Participants
|
4 participants
n=13 Participants
|
4 participants
n=20 Participants
|
|
Primary Diagnosis
syncope
|
0 participants
n=7 Participants
|
1 participants
n=13 Participants
|
1 participants
n=20 Participants
|
|
MRI Indication
Seizure
|
7 Participants
n=7 Participants
|
7 Participants
n=13 Participants
|
14 Participants
n=20 Participants
|
|
MRI Indication
Diplopia
|
0 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=20 Participants
|
|
MRI Indication
Ataxia
|
0 Participants
n=7 Participants
|
4 Participants
n=13 Participants
|
4 Participants
n=20 Participants
|
|
MRI Indication
Syncope
|
0 Participants
n=7 Participants
|
1 Participants
n=13 Participants
|
1 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: a total of 2-3 hours during sedation and recovery.number of participants developing hypotension and or bradycardia
Outcome measures
| Measure |
Dexmedetomidine and Ketamine
n=7 Participants
Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
Ketamine
Dexmedetomidine
|
Dexmedetomidine and Midazolam
n=13 Participants
Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
Midazolam
Dexmedetomidine
|
|---|---|---|
|
The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours)
Hypotension
|
0 Participants
|
0 Participants
|
|
The Number of Participants With Hypotension and/or Bradycardia During Sedation and Recovery (Generally 2-3 Hours)
Bradycardia
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: during sedation and recovery (generally 2-3 hours)Change in heart rate from baseline.
Outcome measures
| Measure |
Dexmedetomidine and Ketamine
n=7 Participants
Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
Ketamine
Dexmedetomidine
|
Dexmedetomidine and Midazolam
n=13 Participants
Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
Midazolam
Dexmedetomidine
|
|---|---|---|
|
Percent Change in Heart Rate From Baseline
|
-29.9 percent change from baseline
Standard Deviation 7.5
|
-29.6 percent change from baseline
Standard Deviation 11.1
|
SECONDARY outcome
Timeframe: during sedation and recovery (generally 2-3 hours)Change in blood pressure from baseline.
Outcome measures
| Measure |
Dexmedetomidine and Ketamine
n=7 Participants
Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
Ketamine
Dexmedetomidine
|
Dexmedetomidine and Midazolam
n=13 Participants
Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
Midazolam
Dexmedetomidine
|
|---|---|---|
|
Percent Change in Blood Pressure From Baseline
|
-18.7 percent change from baseline
Standard Deviation 12.2
|
-14.9 percent change from baseline
Standard Deviation 11.8
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Dexmedetomidine and Ketamine
n=7 Participants
Subjects will already be getting Dexmedetomidine and Ketamine for their routine care.
Ketamine
Dexmedetomidine
|
Dexmedetomidine and Midazolam
n=13 Participants
Subjects will already be getting Dexmedetomidine and Midazolam for their routine care.
Midazolam
Dexmedetomidine
|
|---|---|---|
|
The Number of Participants With Adverse Recovery-related Behaviors During Sedation Recovery
|
0 Participants
|
0 Participants
|
Adverse Events
Dexmedetomidine and Ketamine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dexmedetomidine and Midazolam
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place