Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 14
- Locations
- 1
- Primary Endpoint
- Respiratory depression
Study Overview
Brief Summary
The standard anesthetic care plan for people having adolescent idiopathic scoliosis surgery will be accompanied by a pharmacokinetic simulation of the administered drugs to suggest opportunities to adjust drug doses to achieve tolerable pain control after surgery, avoid respiratory depression and allow patients to respond quickly either during intraoperative testing or at the conclusion of surgery.
Detailed Description
As part of this study, anesthesiologists will be given additional data on the expected drug effects based on a computer simulation. The data will be provided as a suggestion and will be used together with all the other information normally used to keep the study subjects safely asleep during surgery. In addition, data will be collected from the medical history and on postoperative pain control and medication side effects for the first 24 hours. Specifically, study subjects will be asked to rate their pain on a 10-point scale after they wake up from surgery and once they arrive in the pediatric intensive care unit. Measures of the time from the end of surgery until the study subjects are awake and out of the operating room will also be collected.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 10 Years to 18 Years (Child, Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •American Society of Anesthesiologists (ASA) class 1-2
- •At least 10 years of age and not older than 18 years of age
- •Diagnosis of idiopathic adolescent scoliosis
Exclusion Criteria
- •Currently pregnant
- •Currently breastfeeding
- •Currently being treated with opiates
- •Currently being treated with alpha2 agonists
- •Currently being treated with anticonvulsants
- •Currently being treated with antidepressants
- •History of significant restrictive lung disease
Arms & Interventions
Anesthesia optimization
Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA)
Intervention: pharmacokinetic simulation (Other)
Outcomes
Primary Outcomes
Respiratory depression
Time Frame: 24 hours
Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone.
4-Item Pain Intensity Measure
Time Frame: 24 hours
0 - 10 (0=no pain; 10 = pain as bad as can be)
Secondary Outcomes
- Utility of pharmacokinetic simulation(4 - 8 hours (Intraoperative period))