Skeletal Muscle and Adipose Tissue Study

University of Florida

Status and phase: Completed; Phase 4

Conditions: Idiopathic Scoliosis

Treatments: Drug: Continuous Cefazolin drip; Drug: Bolus dose of Cefazolin; Device: Subcutaneous microdialysis catheters; Device: Paraspinal muscle microdialysis catheters

Study type: Interventional

Funder types: Other

Identifiers

NCT03190668

OCR18899 (Other Identifier)

IRB201701129 -A

Details and patient eligibility

About

The purpose of this research study is to compare the current standard of care for prophylactic Cefazolin administered every 3 hours intravenously with continuous infusion of Cefazolin during pediatric spinal surgery.

Full description

Determine the skeletal muscle and adipose tissue disposition of prophylactic Cefazolin using microdialysis sampling in a cohort of patients diagnosed with idiopathic scoliosis undergoing posterior spinal fusion (PSF) for administration of Cefazolin by either continuous infusion or intermittent bolus.

Enrollment: 12 patients

Sex: All

Ages: 12 to 20 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosis of idiopathic scoliosis
• Planned posterior spinal fusion surgery (PSFS)
• Age: 12-20 years old
• American Society of Anesthesiology status I or II undergoing posterior spinal fusion for at least 6 levels
• No known allergy to cefazolin

Exclusion criteria

• Known allergy to cefazolin
• Anatomical or other abnormalities that precluded insertion of a microdialysis catheter into the selected paraspinal muscle
• Known renal or hepatic insufficiency or failure

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

First Regimen Group

Active Comparator group

Description:

The first regimen will consist of a bolus dose of Cefazolin 30mg/kg up to a maximum of 2000mg IV administered prior to surgical incision. The same pre-operative dose of Cefazolin will be repeated every 3 hours until the completion of surgery. Two will paraspinal muscle microdialysis catheters and two subcutaneous microdialysis catheters will be inserted.

Treatment:

Device: Paraspinal muscle microdialysis catheters

Device: Subcutaneous microdialysis catheters

Drug: Bolus dose of Cefazolin

Second Regimen Group

Active Comparator group

Description:

The second regimen will consist of an initial bolus dose of 30 mg/kg up to maximum of 2000 mg. Following the initial bolus dose a continuous Cefazolin drip will start until the end of surgery. Cefazolin drip dose will be 10 mg/(kg\*h) up to maximum of 667 mg/h.Two microdialysis catheters will be inserted into a paraspinal muscle and two microdialysis catheters will be inserted subcutaneously.

Treatment:

Device: Paraspinal muscle microdialysis catheters

Device: Subcutaneous microdialysis catheters

Drug: Continuous Cefazolin drip