An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
Information source: Nationwide Children's Hospital
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Neuromuscular Scoliosis
Intervention: Clevidipine (Drug)
Phase: Phase 2/Phase 3
Status: Completed
Sponsored by: Nationwide Children's Hospital Official(s) and/or principal investigator(s):
Joseph Tobias, MD, Principal Investigator, Affiliation: Nationwide Children's Hospital
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.
Clinical Details
Official title: An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
Study design: Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Time to Achieve Target MAP
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.
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
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)
Locations and Contacts
Nationwide Children's Hospital, Columbus, Ohio 43205, United States
Additional Information
Starting date: June 2012
Last updated: February 3, 2015
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