Skeletal Muscle and Adipose Tissue Study

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

12 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-29

Study Completion Date

2022-06-23

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Idiopathic Scoliosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Simple randomization will be used with each patient has probability 0.5 to be assigned in Group I or Group II. Computer program will generate a uniform random variable between 0 to 1, with subject assigned to Group I if the value is less than 0.5 and assigned to Group II if the value is greater than 0.5.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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First Regimen Group

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.

Group Type ACTIVE_COMPARATOR

Bolus dose of Cefazolin

Intervention Type DRUG

Mode of Cefazolin administration will be a intermittent bolus

Paraspinal muscle microdialysis catheters

Intervention Type DEVICE

Two dialysis probes will be inserted into a paraspinal muscle

Subcutaneous microdialysis catheters

Intervention Type DEVICE

Two dialysis probes will be inserted into a paraspinal subcutaneous region

Second Regimen Group

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.

Group Type ACTIVE_COMPARATOR

Continuous Cefazolin drip

Intervention Type DRUG

Mode of Cefazolin administration will be a continuous drip

Paraspinal muscle microdialysis catheters

Intervention Type DEVICE

Two dialysis probes will be inserted into a paraspinal muscle

Subcutaneous microdialysis catheters

Intervention Type DEVICE

Two dialysis probes will be inserted into a paraspinal subcutaneous region

Interventions

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Bolus dose of Cefazolin

Mode of Cefazolin administration will be a intermittent bolus

Intervention Type DRUG

Continuous Cefazolin drip

Mode of Cefazolin administration will be a continuous drip

Intervention Type DRUG

Paraspinal muscle microdialysis catheters

Two dialysis probes will be inserted into a paraspinal muscle

Intervention Type DEVICE

Subcutaneous microdialysis catheters

Two dialysis probes will be inserted into a paraspinal subcutaneous region

Intervention Type DEVICE

Other Intervention Names

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Standard mode of prophylactic cefazolin administration Continuous infusion of prophylactic cefazolin Paraspinal muscle dialysate sample Subcutaneous dialysate sample

Eligibility Criteria

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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

Minimum Eligible Age

12 Years

Maximum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No