Anesthetic Optimization in Scoliosis Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain; Adolescent Idiopathic Scoliosis; Respiratory Depression
• Interventions: Other: pharmacokinetic simulation

• Registration Number: NCT02481570
• Lead Sponsor: University of Florida

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 Timeline

• Study First Submitted: 2015-06-23
• Study First Submitted QC: 2015-06-23
• Study First Posted: 2015-06-25
• Study Start: 2015-11
• Primary Completion: 2016-11-21
• Study Completion: 2017-08-15
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-09
• Last Update Posted: 2019-08-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 14

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Anesthesia optimization	pharmacokinetic simulation	Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Utility of pharmacokinetic simulation	4 - 8 hours (Intraoperative period)	The number of modifications to the anesthetic dosing

Trial Locations

Locations (1)

UF Health; 🇺🇸 Gainesville, Florida, United States