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Anesthetic Optimization in Scoliosis Surgery (AIS)

Primary Purpose

Adolescent Idiopathic Scoliosis, Respiratory Depression, Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
pharmacokinetic simulation
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Adolescent Idiopathic Scoliosis focused on measuring Adolescent Idiopathic Scoliosis, Scoliosis surgery, Pharmacokinetic simulation

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UF Health

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Anesthesia optimization

Arm Description

Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA)

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Utility of pharmacokinetic simulation
The number of modifications to the anesthetic dosing

Full Information

First Posted
June 23, 2015
Last Updated
August 9, 2019
Sponsor
University of Florida
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1. Study Identification

Unique Protocol Identification Number
NCT02481570
Brief Title
Anesthetic Optimization in Scoliosis Surgery
Acronym
AIS
Official Title
Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
November 2015 (Actual)
Primary Completion Date
November 21, 2016 (Actual)
Study Completion Date
August 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adolescent Idiopathic Scoliosis, Respiratory Depression, Postoperative Pain
Keywords
Adolescent Idiopathic Scoliosis, Scoliosis surgery, Pharmacokinetic simulation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
14 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Anesthesia optimization
Arm Type
Experimental
Arm Description
Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA)
Intervention Type
Other
Intervention Name(s)
pharmacokinetic simulation
Intervention Description
The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.
Primary Outcome Measure Information:
Title
4-Item Pain Intensity Measure
Description
0 - 10 (0=no pain; 10 = pain as bad as can be)
Time Frame
24 hours
Title
Respiratory depression
Description
Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone.
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
Utility of pharmacokinetic simulation
Description
The number of modifications to the anesthetic dosing
Time Frame
4 - 8 hours (Intraoperative period)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Seubert, MD PhD DABNM
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610-3003
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32905725
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.
Results Reference
derived

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Anesthetic Optimization in Scoliosis Surgery

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