Anesthetic Optimization in Scoliosis Surgery
AIS
Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery
1 other identifier
interventional
14
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2015
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 23, 2015
CompletedFirst Posted
Study publicly available on registry
June 25, 2015
CompletedStudy Start
First participant enrolled
November 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 21, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 15, 2017
CompletedAugust 12, 2019
August 1, 2019
1.1 years
June 23, 2015
August 9, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
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 Outcomes (1)
Utility of pharmacokinetic simulation
4 - 8 hours (Intraoperative period)
Study Arms (1)
Anesthesia optimization
EXPERIMENTALInformation from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA)
Interventions
The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
UF Health
Gainesville, Florida, 32610-3003, United States
Related Publications (1)
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.
PMID: 32905725DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Christoph Seubert, MD PhD DABNM
University of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 23, 2015
First Posted
June 25, 2015
Study Start
November 1, 2015
Primary Completion
November 21, 2016
Study Completion
August 15, 2017
Last Updated
August 12, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share