Scoliosis
Conditions
Keywords
dexmedetomidine, neuromonitoring, spine procedures, safe dose, 1- safe dose of dexmedetomidine when used in total intravenous anesthesia for procedures require neuromonitoring, 2- safe dose of propofol when uses in comination with dexmedetomidine in neuromontoring, 3effect of dexmedetomidine on somatosensory evoked potential and motor evoked potentials
Brief summary
Reduction of the spinal cord injuries during scoliosis surgery is a major goal of the anesthesia and surgical team. Despite improvement in scoliosis surgery over the years, the development of neurological deficits remains the most feared complication of spine surgery. During scoliosis surgery it is very important to monitor the spinal cord to detect spinal cord injury with surgical manipulation. Continuous or intermittent intraoperative electrophysiological monitoring (neuron-monitoring) is used routinely during these procedures to provide the surgeon with information concerning the integrity of neurological structures at risk. All neuron-monitoring modalities are affected by the anesthetic regimen used. Of the various intravenous anesthetic drugs, the combination of propofol, remifentanil and dexmedetomidine appear to impact neuron-monitoring the least. The current anesthetic practice is to use the three drugs in combination at doses that do not depress the signals but there is no data relating targeted dexmedetomidine and propofol blood levels to neuron-monitoring signals. The lack of data results in wide variability in dosing with consequent variability in patient response. Hypothesis: Clinically relevant blood levels of dexmedetomidine will affect the amplitude of transcranial motor-evoked potentials (TcMEP) either independently or by interaction with propofol in a dose dependent manner.
Interventions
DRUGlow dexmedetomidine, low propofol
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 100 MCG/KG/M
DRUGhigh dexmedetomidine, low propofol
Dexmedetomidine loading dose 1.1 MCG/KG ,Propofol infusion 100 MCG/KG/M
DRUGDexmedetomidine
Dexmedetomidine loading dose 0.6 MCG/KG,Propofol infusion 200 MCG/KG/M
DRUGDexmedetomidin
Dexmedetomidine loading dose 1.1 MCG/KG.Propofol infusion 200 MCG/KG/M
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 25 Years
Healthy volunteers
No
Inclusion criteria
* Subjects must be 10 to 25 years of age * Diagnosis of idiopathic scoliosis is established * Subject's legal authorized representative has given written, informed consent to participate in the study and, where appropriate, the subject has given assent to participate * American society of Anesthesiology physical status one/two * Patients scheduled for posterior spinal fusion only
Exclusion criteria
* • Patients with neuromuscular scoliosis and patients with motor or sensory deficit in the lower extremities * Patients with allergy to, or contraindication for the drugs or techniques used in the study * Morbid obesity (Body mass index higher than 40) * History of malignant hyperthermia * Patient with severe cardiopulmonary disease (pulmonary hypertension, cardiomyopathy, mechanical ventilation)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Motor Evoked Potential Amplitude | baseline, 30 minutes | The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline. |
Countries
United States
Participant flow
Recruitment details
Enrollment has been completed for this study.
Pre-assignment details
There is no wash out, run-in, or transition period in this protocol
Participants by arm
| Arm | Count |
|---|---|
| Low Dexmedetomidine/Low Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\*\* ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75 | 9 |
| High Dexmedetomidine/Low Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\*\* ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75 | 8 |
| Low Dexmedetomidine/High Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\*\* ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75 | 9 |
| High Dexmedetomidine/High Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\*\* ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75 | 10 |
| Intermediate Dexmedetomidine/Intermediate Propofol Dexmedetomidine Loading Dose, Propofol Loading Dose and Data Collection: After baseline TcMEP measurements are obtained, subject will receive their assigned dexmedetomidine loading dose over a 15 minute period. During this time period, if the subject has been randomized to a Propofol loading dose they will be give it over a 3 minutes period. See Table 2.
TABLE 2: dexmedetomidine and propofol dose schedule.
Dexmedetomidine loading dose mcg/kg Dexmedetomidine infusion mcg/kg/hour for 15 minutes Target dexmedetomidine concentration ng/ml (\*\* ) Propofol loading dose mg/kg Propofol infusion mcg/kg/min Target propofol concentration mcg/ml Group 1 0.6 0.4 0.4 none 100 2.5 Group 2 1.1 0.7 0.8 none 100 2.5 Group 3 0.6 0.4 0.4 0.5 200 5.0 Group 4 1.1 0.7 0.8 0.5 200 5.0 Group 5 0.9 0.5 0.6 0.25 140 3.75 | 8 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Physician Decision | 1 | 0 | 0 | 2 | 1 |
Baseline characteristics
| Characteristic | Low Dexmedetomidine/Low Propofol | High Dexmedetomidine/Low Propofol | Low Dexmedetomidine/High Propofol | High Dexmedetomidine/High Propofol | Intermediate Dexmedetomidine/Intermediate Propofol | Total |
|---|---|---|---|---|---|---|
| Age, Categorical <=18 years | 8 Participants | 8 Participants | 9 Participants | 10 Participants | 8 Participants | 43 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 1 Participants |
| Age Continuous | 16 years STANDARD_DEVIATION 2 | 15 years STANDARD_DEVIATION 2 | 15 years STANDARD_DEVIATION 2 | 15 years STANDARD_DEVIATION 2 | 15 years STANDARD_DEVIATION 2 | 15 years STANDARD_DEVIATION 2 |
| Region of Enrollment United States | 9 participants | 8 participants | 9 participants | 10 participants | 8 participants | 44 participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 9 Participants | 9 Participants | 7 Participants | 35 Participants |
| Sex: Female, Male Male | 5 Participants | 2 Participants | 0 Participants | 1 Participants | 1 Participants | 9 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 7 |
| serious Total, serious adverse events | 0 / 8 | 0 / 8 | 0 / 9 | 0 / 8 | 0 / 7 |
Outcome results
Primary
Motor Evoked Potential Amplitude
The primary outcome measure of the study was the participants who had Motor Evoked Potentials Amplitude significantly reduced (more than 70%)compared to the baseline.
Time frame: baseline, 30 minutes
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Low Dexmedetomidine/Low Propofol | Motor Evoked Potential Amplitude | 1 participants |
| High Dexmedetomidine/Low Propofol | Motor Evoked Potential Amplitude | 3 participants |
| Low Dexmedetomidine/High Propofol | Motor Evoked Potential Amplitude | 1 participants |
| High Dexmedetomidine/High Propofol | Motor Evoked Potential Amplitude | 4 participants |
| Intermediate Dexmedetomidine/Intermediate Propofol | Motor Evoked Potential Amplitude | 4 participants |