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Completed

NCT Number: NCT02481570

Anesthetic Optimization in 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.

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Key information

Conditions

Adolescent Idiopathic Scoliosis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Postoperative Pain Respiration Disorders Respiratory Depression Respiratory Insufficiency Respiratory Tract Diseases Signs and Symptoms

Age range

10 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UF Health

Gainesville, Florida, 32610-3003, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pharmacokinetic simulation

Other

The aim of the simulation is to recommend dosing adjustments to improve postoperative analgesia with a rapid emergence.

Primary outcomes

  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 outcomes

  1. Utility of pharmacokinetic simulation

    Time frame: 4 - 8 hours (Intraoperative period)

    The number of modifications to the anesthetic dosing

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Official study title

Evaluation of an Anesthetic Optimization Technique in Adolescent Idiopathic Scoliosis Surgery

Acronym: AIS

Important dates

Study start
2015
Primary completion
2016
Study completion
2017
First posted
Jun 25, 2015
Registry last updated
Aug 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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