Anesthetic Optimization in Scoliosis Surgery (AIS)

University of Florida

Status: Completed

Conditions: Postoperative Pain; Respiratory Depression; Adolescent Idiopathic Scoliosis

Treatments: Other: pharmacokinetic simulation

Study type: Interventional

Funder types: Other

Identifiers

NCT02481570

IRB201500120

Details and patient eligibility

About

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.

Full 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.

Enrollment: 14 patients

Sex: All

Ages: 10 to 18 years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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14 participants in 1 patient group

Anesthesia optimization

Experimental group

Description:

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

Treatment:

Other: pharmacokinetic simulation