ClinicalTrials.gov
ClinicalTrials.gov Menu

Anesthetic Optimization in Scoliosis Surgery (AIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02481570
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 29, 2018
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Adolescent Idiopathic Scoliosis Respiratory Depression Postoperative Pain Other: pharmacokinetic simulation Not Applicable

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  (Clinical Trial)
Actual Enrollment : 14 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery
Actual Study Start Date : November 2015
Actual Primary Completion Date : November 21, 2016
Actual Study Completion Date : August 15, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Scoliosis

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.




Primary Outcome Measures :
  1. 4-Item Pain Intensity Measure [ Time Frame: 24 hours ]
    0 - 10 (0=no pain; 10 = pain as bad as can be)

  2. Respiratory depression [ Time Frame: 24 hours ]
    Respiratory rate less than 10 breaths per minute (bpm), or administration of naloxone.


Secondary Outcome Measures :
  1. Utility of pharmacokinetic simulation [ Time Frame: 4 - 8 hours (Intraoperative period) ]
    The number of modifications to the anesthetic dosing



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   10 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02481570


Locations
United States, Florida
UF Health
Gainesville, Florida, United States, 32610-3003
Sponsors and Collaborators
University of Florida
Investigators
Principal Investigator: Christoph Seubert, MD PhD DABNM University of Florida

Responsible Party: University of Florida
ClinicalTrials.gov Identifier: NCT02481570     History of Changes
Other Study ID Numbers: IRB201500120
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 29, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by University of Florida:
Adolescent Idiopathic Scoliosis
Scoliosis surgery
Pharmacokinetic simulation

Additional relevant MeSH terms:
Pain, Postoperative
Scoliosis
Respiratory Insufficiency
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Respiration Disorders
Respiratory Tract Diseases
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs