NCT02481570

Anesthetic Optimization in Scoliosis Surgery

Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Florida · Academic / Other
• Sex: All
• Age: 10 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Adolescent Idiopathic Scoliosis
• Respiratory Depression
• Postoperative Pain

Interventions

Type	Name	Description
OTHER	pharmacokinetic simulation	The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.

Timeline

• Start date: 2015-11-01
• Primary completion: 2016-11-21
• Completion: 2017-08-15
• First posted: 2015-06-25
• Last updated: 2019-08-12

Locations

1 site across 1 country: United States