Spinal Fusion
Conditions
Keywords
motor evoked potentials
Brief summary
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on motor evoked potentials during spine surgery
Detailed description
This a parallel group, two-arm, randomized superiority trial that will compare the effect of two different doses of dexmedetomidine on suitability of motor evoked potentials for intraoperative monitoring during spine surgery
Interventions
DRUGDexmedetomidine
Patients will randomly assigned to received Arm 1 anesthesia or Arm 2 anesthesia during surgery.
Sponsors
Hospital for Special Surgery, New York
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Masking description
The anesthesiologist administering anesthetic agents will have knowledge of their doses. The technologist performing motor evoked potential testing and other participants will not.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients undergoing multi-level posterior spine fusions requiring motor evoked potential monitoring
Exclusion criteria
* Allergy to dexmedetomidine, propofol * Conditions knows to make recording of motor evoked potentials difficult, including poorly controlled diabetes, severe peripheral neuropathy, severe myelopathy, or previous surgery during which motor evoked potentials were difficult to obtain * Hepatic disease
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of Patients With Monitorable of Motor Evoked Potentials | During a single surgery for the duration of the operation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| High 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. | 3 |
| Low Dose 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. | 4 |
| Total | 7 |
Baseline characteristics
| Characteristic | Low Dose Dexmedetomidine | Total | High Dose Dexmedetomidine |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 2 Participants | 2 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 2 Participants | 5 Participants | 3 Participants |
| Age, Continuous | 53 years STANDARD_DEVIATION 21 | 53 years STANDARD_DEVIATION 22 | 52 years STANDARD_DEVIATION 29 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 7 participants | 3 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 3 |
| other Total, other adverse events | 0 / 4 | 0 / 3 |
| serious Total, serious adverse events | 0 / 4 | 0 / 3 |
Outcome results
Primary
Percent of Patients With Monitorable of Motor Evoked Potentials
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.
Time frame: During a single surgery for the duration of the operation
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Low Dose Dexmedetomidine | Percent of Patients With Monitorable of Motor Evoked Potentials | 4 Participants |
| High Dose Dexmedetomidine | Percent of Patients With Monitorable of Motor Evoked Potentials | 3 Participants |