Anesthetic Optimization in Scoliosis Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery

Conditions
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Adolescent Idiopathic Scoliosis, Respiratory Depression, Postoperative Pain

Intervention / Treatment
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* Other: pharmacokinetic simulation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anesthesia optimization<br>Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA) | Other: pharmacokinetic simulation<br>* The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 4-Item Pain Intensity Measure | 0 - 10 (0=no pain; 10 = pain as bad as can be) | 24 hours | 
| Respiratory depression | Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone. | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Utility of pharmacokinetic simulation | The number of modifications to the anesthetic dosing | 4 - 8 hours (Intraoperative period) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent Idiopathic Scoliosis, Scoliosis surgery, Pharmacokinetic simulation