An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion
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|ClinicalTrials.gov Identifier: NCT01645111|
Recruitment Status : Completed
First Posted : July 20, 2012
Results First Posted : February 18, 2015
Last Update Posted : February 18, 2015
|Condition or disease||Intervention/treatment||Phase|
|Neuromuscular Scoliosis||Drug: Clevidipine||Phase 2 Phase 3|
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:
- Intravenous or oral premedication with midazolam
- Inhalational or intravenous induction based on the preference of the patient
- Facilitation of endotracheal intubation with a dose of rocuronium with placement of intraoperative monitors including an arterial cannula
- 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.
- Tranexamic acid to limit intraoperative bleeding
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||50 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||An Open-label Trial of Clevidipine for Controlled Hypotension During Spinal Fusion|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||December 2013|
|Actual Study Completion Date :||December 2013|
|Active Comparator: Clevidipine||
- Time to Achieve Target MAP [ Time Frame: First 30 minutes of infusion ]The time between start of clevidipine infusion and patient reaching target mean arterial pressure (MAP) at 55-65 mmHg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01645111
|United States, Ohio|
|Nationwide Children's Hospital|
|Columbus, Ohio, United States, 43205|
|Principal Investigator:||Joseph Tobias, MD||Nationwide Children's Hospital|