Anesthetic Optimization in Scoliosis Surgery (AIS)

August 9, 2019 updated by: University of Florida

Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-3003
        • UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Anesthesia optimization
Information from the pharmacokinetic simulation during an anesthetic regimen of a propofol based Total Intravenous Anesthetic (TIVA)
Other: pharmacokinetic simulation
The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility of pharmacokinetic simulation
Time Frame: 4 - 8 hours (Intraoperative period)
The number of modifications to the anesthetic dosing
4 - 8 hours (Intraoperative period)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Christoph Seubert, MD PhD DABNM, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2015

Primary Completion (Actual)

November 21, 2016

Study Completion (Actual)

August 15, 2017

Study Registration Dates

First Submitted

June 23, 2015

First Submitted That Met QC Criteria

June 23, 2015

First Posted (Estimate)

June 25, 2015

Study Record Updates

Last Update Posted (Actual)

August 12, 2019

Last Update Submitted That Met QC Criteria

August 9, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201500120

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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