Trial Outcomes & Findings for The Effects of Dexmedetomidine Dose on Motor Evoked Potentials (NCT NCT03378973)
NCT ID: NCT03378973
Last Updated: 2020-04-28
Results Overview
Monitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
7 participants
Primary outcome timeframe
During a single surgery for the duration of the operation
Results posted on
2020-04-28
Participant Flow
Participant milestones
| Measure |
Low Dose Dexmedetomidine
Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min
Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
|
Highdose Dexmedetomidine
Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min
Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
|
|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
|
Overall Study
COMPLETED
|
4
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
High Dose Dexmedetomidine
n=3 Participants
Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min
Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
|
Low Dose Dexmedetomidine
n=4 Participants
Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min
Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
|
Total
n=7 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=3 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=7 Participants
|
|
Age, Continuous
|
52 years
STANDARD_DEVIATION 29 • n=3 Participants
|
53 years
STANDARD_DEVIATION 21 • n=4 Participants
|
53 years
STANDARD_DEVIATION 22 • n=7 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=3 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=7 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
3 participants
n=3 Participants
|
4 participants
n=4 Participants
|
7 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: During a single surgery for the duration of the operationMonitorable is defined as stable signals being present in 3 muscles in each lower extremity, with mean peak-to-peak amplitude of at least 50 uV, and with mean-normalized interquartile variability of 0.9 or less.
Outcome measures
| Measure |
Low Dose Dexmedetomidine
n=4 Participants
Patients will receive dexmedetomidine 0.5 mcg/kg/hr plus propofol 50 mcg/kg/min
Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
|
High Dose Dexmedetomidine
n=3 Participants
Patients will receive dexmedetomidine 1.0 mcg/kg/hr plus propofol 25 mcg/kg/min
Dexmedetomidine: Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
|
|---|---|---|
|
Percent of Patients With Monitorable of Motor Evoked Potentials
|
4 Participants
|
3 Participants
|
Adverse Events
Low Dose Dexmedetomidine
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
High Dose Dexmedetomidine
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