Clinical trial NCT02481570: Anesthetic Optimization in Scoliosis Surgery
Official title: Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adolescent Idiopathic Scoliosis
Respiratory Depression
Postoperative Pain
Keywords: Adolescent Idiopathic Scoliosis
Scoliosis surgery
Pharmacokinetic simulation
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2015-06-25
Enrollment: 14
Sex: ALL
Minimum age (years): 10
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: 4-Item Pain Intensity Measure
timeFrame: 24 hours
measure: Respiratory depression
timeFrame: 24 hours
Secondary outcomes:
measure: Utility of pharmacokinetic simulation
timeFrame: 4 - 8 hours (Intraoperative period)
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health
state: Florida
Study officials:
affiliation: University of Florida
name: Christoph Seubert, MD PhD DABNM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Tams C, Dooley FC, Sangari TS, Gonzalez-Rodriguez SN, Stoker RE, Phillips SA, Koenig M, Wishin JM, Molinari SC, Blakemore LC, Seubert CN. Methadone and a Clinical Pathway in Adolescent Idiopathic Scoliosis Surgery: A Historically Controlled Study. Global Spine J. 2020 Oct;10(7):837-843. doi: 10.1177/2192568219878135. Epub 2019 Sep 26.