Neuromuscular Scoliosis
Conditions
Brief summary
The current study would prospectively evaluate the dosing requirements, efficacy and safety of clevidipine for controlled hypotension during spinal surgery in the pediatric population. As the investigators currently have projects underway which include those patients having scoliosis surgery for idiopathic scoliosis, this trial would include only those undergoing scoliosis surgery for neuromuscular disease.
Detailed description
This would basically be an observational study without a significant change in our current practice. There would be no change in the standard and usual anesthetic care including premedication, anesthetic induction, intraoperative anesthetic management, and intraoperative monitoring. Our usual anesthetic routine includes: 1. Intravenous or oral premedication with midazolam 2. Inhalational or intravenous induction based on the preference of the patient 3. Facilitation of endotracheal intubation with a dose of rocuronium with placement of intraoperative monitors including an arterial cannula 4. Maintenance anesthesia to include desflurane titrated to maintain the bispectral index at 40-60, fentanyl 2-4 µg/kg followed by a remifentanil infusion to maintain the mean arterial pressure at 55-65 mmHg. 5. Tranexamic acid to limit intraoperative bleeding 6. As needed, agent to control blood pressure to maintain the MAP at 55-65 mmHg if remifentanil in doses up to 0.3 µg/kg/min are ineffective. As needed, clevidipine will be started at 1 µg/kg/min and titrated up in 1 µg/kg/min every 1-2 minutes to achieve an MAP at 55-65mmHg. Vital signs including heart rate will be recorded every 1 minute until the target MAP is achieved and then at 15 minute increments after that.
Interventions
DRUGClevidipine
Sponsors
Nationwide Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Spinal fusion for neuromuscular scoliosis.
Exclusion criteria
* Allergy to dihydropyridine calcium channel antagonists * Allergy to soy or eggs * Non-neuromuscular causes of scoliosis * Disorders of lipid metabolism (clevidipine is in a lipid base)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Achieve Target MAP | First 30 minutes of infusion | The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clevidipine Clevidipine | 50 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Did not require Clevidipine | 15 |
Baseline characteristics
| Characteristic | Clevidipine |
|---|---|
| Age, Categorical <=18 years | 47 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 3 Participants |
| Age, Continuous | 14.6 years STANDARD_DEVIATION 3.2 |
| Region of Enrollment United States | 50 participants |
| Sex: Female, Male Female | 24 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 0 / 50 |
Outcome results
Primary
Time to Achieve Target MAP
The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg
Time frame: First 30 minutes of infusion
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clevidipine | Time to Achieve Target MAP | 9.2 minutes | Standard Deviation 11.4 |